Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-06

Study Completion Date

2021-06-22

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Test Article - Zip-stitch Clips

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Group Type EXPERIMENTAL

Zip-stitch(TM)

Intervention Type DEVICE

The assigned intervention is used to close the cuff following colpotomy.

Reference Group - V-Loc Barbed Suture

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

Group Type OTHER

Zip-stitch(TM)

Intervention Type DEVICE

The assigned intervention is used to close the cuff following colpotomy.

Interventions

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Zip-stitch(TM)

The assigned intervention is used to close the cuff following colpotomy.

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes