Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00737425
Collaborator
Nanovibronix (Industry)
80
1
2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery
Study Start Date
:
Sep 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1
|
Device: PainShield
|
| Sham Comparator: 2
|
Device: Sham PainShield
|
Outcome Measures
Primary Outcome Measures
- Pain and discomfort will be measured using appropriate validated questionnaires. [Pain assessment will be performed daily]
Secondary Outcome Measures
- Infections will be assessed by concomitant antibiotic intake [Concomitant medications will be assessed daily]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject's Age ≥ 18
-
Subject is able, agrees and signs the Informed Consent Form
-
Subject requires laparoscopic-assisted abdominal surgery
-
Incision size following the laparoscopy between 4-7 cm
Exclusion Criteria:
-
Epidural analgesia
-
IV PCA
-
Subject has any condition, which precludes compliance with study and/or device instructions
-
Subject is currently participating in another clinical study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shaare Zedek Medical Center | Jerusalem | Israel |
Sponsors and Collaborators
- Shaare Zedek Medical Center
- Nanovibronix
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00737425
Other Study ID Numbers:
- NV-PS-02-001
First Posted:
Aug 19, 2008
Last Update Posted:
Oct 28, 2008
Last Verified:
Oct 1, 2008
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