Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test Article - Zip-stitch Clips Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy |
Device: Zip-stitch(R)
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
|
| Other: Reference Group Will not be comparative against the test article, but will be performed for reference and safety. |
Device: Reference suture
Standard suture for vaginal cuff closure during laparoscopic hysterectomy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence. [This will be evaluated through six-weeks post-operative.]
Frequency of vaginal cuff dehiscence
- Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure. [This will be evaluated through six weeks post operative.]
Frequency of implant passing
Secondary Outcome Measures
- Number of Participants With Successful Vaginal Cuff Closure [Performed at one week, six weeks, and six months after surgery]
Binary, visual surgeon cuff closure evaluation.
- Number of Participants With Vaginal Cuff Healing [Performed at six weeks, and six months after surgery]
Binary, visual surgeon cuff healing evaluation.
- Comparison of Number of Participants With Implant Passing - Test to Reference [Evaluated at six weeks and six months post-operative]
Percentage of subjects experiencing implant passing will be compared between test and reference groups.
- Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety [Evaluated through six-month follow-up]
Each reported implant passing event will be evaluated for association with adverse events. Compared as a percentage of patients in the test vs. reference groups.
- Comparison of Incidence of Adverse Events - Test to Reference [Evaluated through six-month follow-up]
Adverse events and serious adverse events will be tabulated for both the test and reference groups.
- Number of Participants With Non-increase in Dyspareunia at Follow-up [Evaluated through six-month follow-up]
Non-increase in reported individual subject dyspareunia from baseline to six month follow-up will be compared (test versus reference group) using the relevant sexual discomfort module of the Female Sexual Function Index (FSFI). The FSFI is a validated metric of female sexual function, where lower scores indicate poor sexual function. Non-increase in sexual discomfort will be compared between test and control groups.
- Number of Participants With Non-increase in Pain at Follow-up [Evaluated through six-month follow-up]
Non-increase in reported individual subject pain from baseline to six-month follow-up will be compared (test versus reference group) using an 11-point Numerical Rating Scale, where 0 indicates no pain, and 10 indicates maximum possible pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
- Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy)
Exclusion Criteria:
-
History of Human Immunodeficiency Virus (HIV)
-
History of Hepatitis C
-
History of diabetes that, in the opinion of the investigator, may delay healing
-
Current use of systemic corticosteroids
-
Active infection of genitals, vagina, cervix, uterus or urinary tract
-
Active bacteremia, sepsis or other active systemic infection
-
Presence of Sexually Transmitted Infection (STI)
-
Evidence of pelvic inflammatory disease (PID)
-
Known clotting defects or bleeding disorders
-
Hemoglobin < 8 g/dL
-
Metastatic disease
-
On anticoagulant therapy
-
Participation in another interventional trial
-
Pregnancy
-
Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing
-
Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
-
Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
-
Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
-
Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
-
Intra-operative: Cases requiring conversion to laparotomy prior to study intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
Sponsors and Collaborators
- ZSX Medical LLC
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: David Holtz, MD, Main Line Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QD-PRO-054 Rev001
- R44HD104539