Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03187002
Collaborator
(none)
109
1
2
21.4
5.1
Study Details
Study Description
Brief Summary
High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial
Actual Study Start Date
:
Jan 18, 2018
Actual Primary Completion Date
:
Oct 31, 2019
Actual Study Completion Date
:
Oct 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS) |
Device: Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
Other: SHAM: Moderate IV Sedation
Sham IV to ensure blinding
|
| Active Comparator: Moderate IV Sedation Fentanyl, versed |
Drug: Moderate IV Sedation
IV sedation with fentanyl and versed
Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)
Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
|
Outcome Measures
Primary Outcome Measures
- Aspiration Pain [Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)]
Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Secondary Outcome Measures
- Speculum Placement Pain [Intraoperative, collected during procedure (up to 30 seconds)]
Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
- Tenaculum Placement Pain [Intraoperative, collected during procedure (up to 30 seconds)]
Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
- Paracervical Block Pain [Intraoperative, collected during procedure (up to 30 seconds)]
Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
- Manual Cervical Dilation Pain [Intraoperative, collected during procedure (up to 30 seconds)]
Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
- Speculum Removal Pain [Intraoperative, collected during procedure (up to 30 seconds)]
Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
- Total Procedure Time [Intraoperative, collected during procedure (up to 20 minutes)]
Time from speculum placement to speculum removal, measured in minutes
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Presenting for surgical abortion
-
Gestational age <12 weeks
-
< 18 years of age
-
Agrees to be randomized
Exclusion criteria:
-
Allergy to study medications (lidocaine, fentanyl, midazolam)
-
18 years of age
-
Fetal demise
-
Pre-procedure use of misoprostol
-
No means of transportation following procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Planned Parenthood Mar Monte | San Jose | California | United States | 95126 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Principal Investigator, MD, Stanford University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT03187002
Other Study ID Numbers:
- IRB-41589
First Posted:
Jun 14, 2017
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Study Results
Participant Flow
| Recruitment Details | All recruitment occurred at the Planned Parenthood site. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Period Title: Overall Study | ||
| STARTED | 55 | 54 |
| COMPLETED | 55 | 54 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation | Total |
|---|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding | Total of all reporting groups |
| Overall Participants | 55 | 54 | 109 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
26
(5.5)
|
28
(6)
|
27
(6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
55
100%
|
54
100%
|
109
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
21
38.2%
|
26
48.1%
|
47
43.1%
|
| Not Hispanic or Latino |
32
58.2%
|
25
46.3%
|
57
52.3%
|
| Unknown or Not Reported |
2
3.6%
|
3
5.6%
|
5
4.6%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
1.9%
|
1
0.9%
|
| Asian |
12
21.8%
|
10
18.5%
|
22
20.2%
|
| Native Hawaiian or Other Pacific Islander |
1
1.8%
|
2
3.7%
|
3
2.8%
|
| Black or African American |
4
7.3%
|
4
7.4%
|
8
7.3%
|
| White |
21
38.2%
|
17
31.5%
|
38
34.9%
|
| More than one race |
3
5.5%
|
5
9.3%
|
8
7.3%
|
| Unknown or Not Reported |
14
25.5%
|
15
27.8%
|
29
26.6%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
55
100%
|
54
100%
|
109
100%
|
| Gestational Age (days) [Median (Full Range) ] | |||
| Median (Full Range) [days] |
53
|
58
|
55
|
Outcome Measures
| Title | Aspiration Pain |
|---|---|
| Description | Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") |
| Time Frame | Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Measure Participants | 46 | 54 |
| Median (Full Range) [units on a scale] |
73
|
66
|
| Title | Speculum Placement Pain |
|---|---|
| Description | Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") |
| Time Frame | Intraoperative, collected during procedure (up to 30 seconds) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Measure Participants | 46 | 54 |
| Median (Full Range) [units on a scale] |
27
|
17.5
|
| Title | Tenaculum Placement Pain |
|---|---|
| Description | Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") |
| Time Frame | Intraoperative, collected during procedure (up to 30 seconds) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Measure Participants | 46 | 54 |
| Median (Full Range) [units on a scale] |
34.5
|
23.5
|
| Title | Paracervical Block Pain |
|---|---|
| Description | Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") |
| Time Frame | Intraoperative, collected during procedure (up to 30 seconds) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Measure Participants | 46 | 54 |
| Median (Full Range) [units on a scale] |
48.5
|
34.5
|
| Title | Manual Cervical Dilation Pain |
|---|---|
| Description | Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") |
| Time Frame | Intraoperative, collected during procedure (up to 30 seconds) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Measure Participants | 46 | 54 |
| Median (Full Range) [units on a scale] |
67
|
56
|
| Title | Speculum Removal Pain |
|---|---|
| Description | Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable") |
| Time Frame | Intraoperative, collected during procedure (up to 30 seconds) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Measure Participants | 46 | 54 |
| Median (Full Range) [units on a scale] |
38.5
|
23
|
| Title | Total Procedure Time |
|---|---|
| Description | Time from speculum placement to speculum removal, measured in minutes |
| Time Frame | Intraoperative, collected during procedure (up to 20 minutes) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis. |
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation |
|---|---|---|
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding |
| Measure Participants | 46 | 54 |
| Median (Full Range) [minutes] |
7
|
6.4
|
Adverse Events
| Time Frame | Up to 4 hours | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation | ||
| Arm/Group Description | Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. SHAM: Moderate IV Sedation: Sham IV to ensure blinding | Fentanyl, versed Moderate IV Sedation: IV sedation with fentanyl and versed SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding | ||
All Cause Mortality |
||||
| Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/54 (0%) | ||
Serious Adverse Events |
||||
| Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/54 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/54 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Research Manager |
|---|---|
| Organization | Stanford University |
| Phone | 6507211567 |
| fpresearch@stanford.edu |
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT03187002
Other Study ID Numbers:
- IRB-41589
First Posted:
Jun 14, 2017
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020