Clinical trial NCT04081727: Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
Official title: Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laparoscopic Hysterectomy
Lead sponsor: ZSX Medical LLC
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (V-LOC barbed suture).

Detailed description: This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic 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, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post operatively.

Eligibility criteria: Inclusion Criteria:

1. 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 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (may include TLH, LAVH, robotic assisted vaginal hysterectomy)

Exclusion Criteria:

1. History of HIV
2. History of Hepatitis C
3. History of diabetes, that in the opinion of the investigator may delay healing
4. Current use of systemic corticosteroids
5. Active infection of genitals, vagina, cervix, uterus or urinary tract
6. Active bacteremia, sepsis or other active systemic infection
7. Presence of Sexually Transmitted Infection (STI)
8. Evidence of pelvic inflammatory disease (PID)
9. Known clotting defects or bleeding disorders
10. Hemoglobin \< 8 g/dL
11. Metastatic disease
12. On anticoagulant therapy
13. Participation in another interventional trial
14. Pregnancy
15. Abnormal PAP results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing
16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
17. Intra-op: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure

16. Intra-op: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 17. Intra-op: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically 18. Intra-op: Cases requiring conversion to laparotomy prior to study intervention

Primary outcomes:
measure: Primary Efficacy Endpoint - Number of Participants With Implant Passing
timeFrame: Six-weeks post-operative
measure: Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
timeFrame: Six-weeks post-operative
Secondary outcomes:
measure: Number of Participants With Successful Vaginal Cuff Closure
timeFrame: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
measure: Number of Participants With Vaginal Cuff Healing
timeFrame: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
measure: Comparison of Number of Participants With Implant Passing - Test to Reference
timeFrame: evaluated at six months post-operative
measure: Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety
timeFrame: Evaluated after one week, six week, six month, and twelve month follow-up
measure: Comparison of Incidence of Adverse Events - Test to Reference
timeFrame: Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time
measure: Number of Participants With Non-increase in Dyspareunia at Follow-up
timeFrame: Six-months post-operative and again at 12 months post-operative
measure: Number of Participants With Non-increase in Pain at Follow-up
timeFrame: Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
Study officials:
affiliation: Main Line Health
name: David O Holtz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: