Clinical Trials

Clinical Trial Number: ZipStitch

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

Study ID: ZipStitch
Phase N/A
Physician Investigator(s)
Study Locations

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.

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