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

NCT04081727 | Terminated Results DMC FDA Device

• 1 other identifier: QD-PRO-045 Rev002
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint - Number of Participants With Implant Passing

  Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks

  Six-weeks post-operative

• Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence

  Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.

  Six-weeks post-operative

Secondary Outcomes (7)

• Number of Participants With Successful Vaginal Cuff Closure

  Performed at one week, six weeks, and six months after surgery; reported here at six weeks

• Number of Participants With Vaginal Cuff Healing

  Performed at one week, six weeks, and six months after surgery; reported here at six weeks

• Comparison of Number of Participants With Implant Passing - Test to Reference

  evaluated at six months post-operative

• Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety

  Evaluated after one week, six week, six month, and twelve month follow-up

• Comparison of Incidence of Adverse Events - Test to Reference

  Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time

Study Arms (2)

Test Article - Zip-stitch Clips

EXPERIMENTAL

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Device: Zip-stitch(TM)

Reference Group - V-Loc Barbed Suture

OTHER

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

Device: Zip-stitch(TM)

Interventions

Zip-stitch(TM) DEVICE

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

Reference Group - V-Loc Barbed Suture; Test Article - Zip-stitch Clips

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female subjects are eligible to participate in this study as it concerns intervention during laparoscopic hysterectomy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 (may include TLH, LAVH, robotic assisted vaginal hysterectomy)

You may not qualify if:

• 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

Sponsors & Collaborators

• ZSX Medical LLC: lead

Study Sites (1)

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Limitations and Caveats

After the second surgery, enrollment was stopped for reasons unrelated to the study design or test article. The study was not resumed, so enrollment was ended with two subjects. There were not sufficient data to draw meaningful conclusions from the data.

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: ZSX Medical, LLC

info@zsxmedical.com

617-631-8865

Study Officials

• David O Holtz, M.D.

  Main Line Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: November 6, 2019
• Primary Completion: August 31, 2020
• Study Completion: June 22, 2021
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-08

Locations

US (1)