Status:
TERMINATED
Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
Lead Sponsor:
ZSX Medical LLC
Conditions:
Laparoscopic Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 fol...
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. Partic...
Eligibility Criteria
Inclusion
- 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
- History of 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 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-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
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04081727
Start Date
November 6 2019
End Date
June 22 2021
Last Update
September 7 2022
Active Locations (1)
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1
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096