Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy

Completed · Not applicable

Conditions studied: Laparoscopic Hysterectomy

In brief

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.

Key facts

Study ID

NCT05570916

Run by

ZSX Medical LLC

People needed

23

Starts

2023-08-17

Expected to finish

2025-05-10

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Unified Women's Clinical Research — Winston-Salem, North Carolina, United States
• Lankenau Hospital — Wynnewood, Pennsylvania, United States
• Tidewater Clinical Research — Virginia Beach, Virginia, United States
• Mon Health Medical Center — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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