Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study

ZSX Medical

Status: Terminated

Conditions: Laparoscopic Hysterectomy

Treatments: Device: Zip-stitch(TM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04081727

QD-PRO-045 Rev002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

18. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups

Test Article - Zip-stitch Clips

Experimental group

Description:

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Treatment:

Device: Zip-stitch(TM)

Reference Group - V-Loc Barbed Suture

Other group

Description:

Will not be comparative against the test article, but will be performed for reference and safety.

Treatment:

Device: Zip-stitch(TM)