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

Primary Purpose

Laparoscopic Hysterectomy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Zip-stitch(R)

Reference suture

About this trial

This is an interventional treatment trial for Laparoscopic Hysterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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 (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy)

Exclusion Criteria:

History of Human Immunodeficiency Virus (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 Papanicolaou test (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-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
Intra-operative: Cases requiring conversion to laparotomy prior to study intervention

Sites / Locations

Northwestern UniversityRecruiting
Lankenau HospitalRecruiting
Tidewater Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test Article - Zip-stitch Clips

Reference Group

Arm Description

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

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

Outcomes

Primary Outcome Measures

Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence.

Frequency of vaginal cuff dehiscence

Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure.

Frequency of implant passing

Secondary Outcome Measures

Number of Participants With Successful Vaginal Cuff Closure

Binary, visual surgeon cuff closure evaluation.

Number of Participants With Vaginal Cuff Healing

Binary, visual surgeon cuff healing evaluation.

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

Percentage of subjects experiencing implant passing will be compared between test and reference groups.

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

Each reported implant passing event will be evaluated for association with adverse events. Compared as a percentage of patients in the test vs. reference groups.

Comparison of Incidence of Adverse Events - Test to Reference

Adverse events and serious adverse events will be tabulated for both the test and reference groups.

Number of Participants With Non-increase in Dyspareunia at Follow-up

Non-increase in reported individual subject dyspareunia from baseline to six month follow-up will be compared (test versus reference group) using the relevant sexual discomfort module of the Female Sexual Function Index (FSFI). The FSFI is a validated metric of female sexual function, where lower scores indicate poor sexual function. Non-increase in sexual discomfort will be compared between test and control groups.

Number of Participants With Non-increase in Pain at Follow-up

Non-increase in reported individual subject pain from baseline to six-month follow-up will be compared (test versus reference group) using an 11-point Numerical Rating Scale, where 0 indicates no pain, and 10 indicates maximum possible pain.

Full Information

NCT ID

NCT05570916

First Posted

October 4, 2022

Last Updated

October 12, 2023

Sponsor

ZSX Medical LLC

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT05570916

Brief Title

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

Acronym

ZIMS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 17, 2023 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZSX Medical LLC

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive 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 and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Hysterectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test Article - Zip-stitch Clips

Arm Type

Experimental

Arm Description

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Arm Title

Reference Group

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Zip-stitch(R)

Intervention Description

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Intervention Type

Device

Intervention Name(s)

Reference suture

Other Intervention Name(s)

V-Loc or VICRYL sutures

Intervention Description

Standard suture for vaginal cuff closure during laparoscopic hysterectomy

Primary Outcome Measure Information:

Title

Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence.

Description

Frequency of vaginal cuff dehiscence

Time Frame

This will be evaluated through six-weeks post-operative.

Title

Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure.

Description

Frequency of implant passing

Time Frame

This will be evaluated through six weeks post operative.

Secondary Outcome Measure Information:

Title

Number of Participants With Successful Vaginal Cuff Closure

Description

Binary, visual surgeon cuff closure evaluation.

Time Frame

Performed at one week, six weeks, and six months after surgery

Title

Number of Participants With Vaginal Cuff Healing

Description

Binary, visual surgeon cuff healing evaluation.

Time Frame

Performed at six weeks, and six months after surgery

Title

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

Description

Percentage of subjects experiencing implant passing will be compared between test and reference groups.

Time Frame

Evaluated at six weeks and six months post-operative

Title

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

Description

Each reported implant passing event will be evaluated for association with adverse events. Compared as a percentage of patients in the test vs. reference groups.

Time Frame

Evaluated through six-month follow-up

Title

Comparison of Incidence of Adverse Events - Test to Reference

Description

Adverse events and serious adverse events will be tabulated for both the test and reference groups.

Time Frame

Evaluated through six-month follow-up

Title

Number of Participants With Non-increase in Dyspareunia at Follow-up

Description

Time Frame

Evaluated through six-month follow-up

Title

Number of Participants With Non-increase in Pain at Follow-up

Description

Time Frame

Evaluated through six-month follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: History of Human Immunodeficiency Virus (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 Papanicolaou test (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-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically Intra-operative: Cases requiring conversion to laparotomy prior to study intervention

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Samantha Sam, BS

Phone

7343531862

ssam@zsxmedical.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dan O Mazzucco, PhD

Phone

2157043728

dmazzucco@zsxmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Holtz, MD

Organizational Affiliation

Main Line Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Grace, PhD

anne@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Edward Tanner, MD, MBA

Facility Name

Lankenau Hospital

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David O Holtz, M.D

Phone

610-560-8940

holtzd@mlhs.org

Facility Name

Tidewater Clinical Research

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23456

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

April Rusch

Phone

757-471-3375

Ext

First Name & Middle Initial & Last Name & Degree

Mehdi Parva, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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