Clinical trial NCT05570916: Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
Official title: Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Laparoscopic Hysterectomy
Keywords: Hysterectomy
Laparoscopic hysterectomy
minimally invasive hysterectomy
Lead sponsor: ZSX Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-10-07
Enrollment: 59
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.

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.

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 (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy)

Exclusion Criteria:

1. History of Human Immunodeficiency Virus (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 Papanicolaou test (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-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
20. Intra-operative: Cases requiring conversion to laparotomy prior to study intervention

Primary outcomes:
measure: Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence.
timeFrame: This will be evaluated through six-weeks post-operative.
measure: Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure.
timeFrame: This will be evaluated through 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
measure: Number of Participants With Vaginal Cuff Healing
timeFrame: Performed at six weeks, and six months after surgery
measure: Comparison of Number of Participants With Implant Passing - Test to Reference
timeFrame: Evaluated at six weeks and six months post-operative
measure: Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety
timeFrame: Evaluated through six-month follow-up
measure: Comparison of Incidence of Adverse Events - Test to Reference
timeFrame: Evaluated through six-month follow-up
measure: Number of Participants With Non-increase in Dyspareunia at Follow-up
timeFrame: Evaluated through six-month follow-up
measure: Number of Participants With Non-increase in Pain at Follow-up
timeFrame: Evaluated through six-month follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research
state: Virginia
city: Morgantown
country: United States
facility: Mon Health Medical Center
state: West Virginia
Study officials:
affiliation: Main Line Health
name: David Holtz, MD
role: PRINCIPAL_INVESTIGATOR
References: