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TerminatedNCT04081727Updated Sep 7, 2022Results posted

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

An interventional study of Zip-stitch(TM) in Laparoscopic Hysterectomy, sponsored by ZSX Medical LLC. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by ZSX Medical LLC · Not applicable, Interventional, and Treatment

Why this study was terminated
After the second surgery, enrollment was stopped for reasons unrelated to the study design or test article.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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).

Read the 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. 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.

02

Conditions studied

  • Laparoscopic Hysterectomy
03

In context

Lead sponsor

ZSX Medical LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
  1. 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Test Article - Zip-stitch Clips

    Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

    Device: Zip-stitch(TM)

  • Other
    Reference Group - V-Loc Barbed Suture

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

    Device: Zip-stitch(TM)

Interventions

  • DeviceZip-stitch(TM)

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

06

What researchers measure

Primary outcomes

  1. Primary Efficacy Endpoint - Number of Participants With Implant Passing

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

    Time frame: Six-weeks post-operative

  2. Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence

    Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.

    Time frame: Six-weeks post-operative

Secondary outcomes

  1. Number of Participants With Successful Vaginal Cuff Closure

    Binary, visual surgeon cuff closure evaluation

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

  2. Number of Participants With Vaginal Cuff Healing

    Binary, visual surgeon cuff healing evaluation

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

  3. 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

    Time frame: evaluated at six months post-operative

  4. 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.

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

  5. 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.

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

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

    Non-increase in reported individual subject dyspareunia from baseline to 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.

    Time frame: Six-months post-operative and again at 12 months post-operative

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

    Non-increase in reported individual subject pain from baseline to 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.

    Time frame: Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase

07

Results

Posted Sep 7, 2022
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.

Participant flow

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.

Participant flow — Overall Study
MilestoneTest Article - Zip-stitch(TM) ClipsReference Group - Vicryl Suture
Started20
As-treated analysis11
Completed20
Not completed00

Outcome measures

PrimaryPrimary Efficacy Endpoint - Number of Participants With Implant Passing

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

Time frame:
Six-weeks post-operative
Reported as:
Count of participants · Participants
Primary Efficacy Endpoint - Number of Participants With Implant Passing
ParticipantsTest Article - Zip-stitch ClipsReference Group - VICRYL Suture
Primary Efficacy Endpoint - Number of Participants With Implant Passing01
PrimaryPrimary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence

Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.

Time frame:
Six-weeks post-operative
Reported as:
Count of participants · Participants
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence00
SecondaryNumber of Participants With Successful Vaginal Cuff Closure

Binary, visual surgeon cuff closure evaluation

Time frame:
Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Reported as:
Count of participants · Participants
Number of Participants With Successful Vaginal Cuff Closure
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Number of Participants With Successful Vaginal Cuff Closure10
SecondaryNumber of Participants With Vaginal Cuff Healing

Binary, visual surgeon cuff healing evaluation

Time frame:
Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Reported as:
Count of participants · Participants
Number of Participants With Vaginal Cuff Healing
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Number of Participants With Vaginal Cuff Healing10
SecondaryComparison of Number of Participants With Implant Passing - Test to Reference

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

Time frame:
evaluated at six months post-operative
Reported as:
Count of participants · Participants
Comparison of Number of Participants With Implant Passing - Test to Reference
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Comparison of Number of Participants With Implant Passing - Test to Reference11
SecondaryPercentage 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.

Time frame:
Evaluated after one week, six week, six month, and twelve month follow-up
Reported as:
Count of participants · Participants
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety00
SecondaryComparison of Incidence of Adverse Events - Test to Reference

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

Time frame:
Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time
Reported as:
Count of participants · Participants
Comparison of Incidence of Adverse Events - Test to Reference
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Comparison of Incidence of Adverse Events - Test to Reference10
SecondaryNumber of Participants With Non-increase in Dyspareunia at Follow-up

Non-increase in reported individual subject dyspareunia from baseline to 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.

Time frame:
Six-months post-operative and again at 12 months post-operative
Reported as:
Count of participants · Participants
Number of Participants With Non-increase in Dyspareunia at Follow-up
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Number of Participants With Non-increase in Dyspareunia at Follow-up00
SecondaryNumber of Participants With Non-increase in Pain at Follow-up

Non-increase in reported individual subject pain from baseline to 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.

Time frame:
Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase
Reported as:
Count of participants · Participants
Number of Participants With Non-increase in Pain at Follow-up
ParticipantsTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Number of Participants With Non-increase in Pain at Follow-up11

Adverse events

Collected over One year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Article - Zip-stitch Clips0/1 (0%)0/1 (0%)1/1 (100%)
Reference Group - Vicryl Suture0/1 (0%)0/1 (0%)0/1 (0%)
Most frequent other events
Most frequent other events
EventTest Article - Zip-stitch ClipsReference Group - Vicryl Suture
Cuff cellulitisReproductive system and breast disorders1/10/1

Baseline characteristics

Study was stopped after two subjects enrolled

Age, Continuous
Age, Continuous(years)Test Article - Zip-stitch ClipsReference Group - Vicryl SutureTotal
Mean43 ± 3—43 ± 3
Sex: Female, Male
Sex: Female, Male(Participants)Test Article - Zip-stitch ClipsReference Group - Vicryl SutureTotal
Female202
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Test Article - Zip-stitch ClipsReference Group - Vicryl SutureTotal
Hispanic or Latino000
Not Hispanic or Latino202
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Test Article - Zip-stitch ClipsReference Group - Vicryl SutureTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American101
White101
More than one race000
Unknown or Not Reported000
Height
Height(inches)Test Article - Zip-stitch ClipsReference Group - Vicryl SutureTotal
Mean64.5 ± 3.5—64.5 ± 3.5
Weight
Weight(pounds)Test Article - Zip-stitch ClipsReference Group - Vicryl SutureTotal
Mean164.5 ± 39.5—164.5 ± 39.5
08

Study locations

1 site
  • Lankenau Medical Center
    Wynnewood, Pennsylvania 19096, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 6, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04081727
Lead sponsor
ZSX Medical LLC
Responsible party
Sponsor
First posted
Sep 9, 2019
Start date
Nov 6, 2019
Primary completion
Aug 31, 2020
Completion
Jun 22, 2021
Results posted
Sep 7, 2022
Last update
Sep 7, 2022

Study contacts

David O Holtz, M.D.
principal investigator · Main Line Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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