Trial Outcomes & Findings for Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study (NCT NCT04081727)

NCT ID: NCT04081727

Last Updated: 2022-09-07

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: Six-weeks post-operative
• Results posted on: 2022-09-07

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 milestones

Measure	Test Article - Zip-stitch(TM) Clips Zip-stitch(TM) clips for vaginal cuff closure during laparoscopic hysterectomy Zip-stitch(TM): The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly p dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - Vicryl Suture Will not be comparative against the test article, but will be performed for reference and safety.
Overall Study STARTED	2	0
Overall Study As-treated Analysis	1	1
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Test Article - Zip-stitch Clips n=2 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - Vicryl Suture Will not be compared against the test article, but will be performed for reference and safety.	Total n=2 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 3 • n=5 Participants	—	43 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Height	64.5 inches STANDARD_DEVIATION 3.5 • n=5 Participants	—	64.5 inches STANDARD_DEVIATION 3.5 • n=5 Participants
Weight	164.5 pounds STANDARD_DEVIATION 39.5 • n=5 Participants	—	164.5 pounds STANDARD_DEVIATION 39.5 • n=5 Participants

PRIMARY outcome

Timeframe: Six-weeks post-operative

Population: Data analyzed "as-treated."

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

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Primary Efficacy Endpoint - Number of Participants With Implant Passing	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Six-weeks post-operative

Population: Data analyzed "as treated."

Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence	0 Participants	0 Participants

SECONDARY outcome

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

Population: Data analyzed "as treated."

Binary, visual surgeon cuff closure evaluation

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Number of Participants With Successful Vaginal Cuff Closure	1 Participants	0 Participants

SECONDARY outcome

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

Population: Data analyzed "as treated."

Binary, visual surgeon cuff healing evaluation

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Number of Participants With Vaginal Cuff Healing	1 Participants	0 Participants

SECONDARY outcome

Timeframe: evaluated at six months post-operative

Population: Data analyzed "as treated."

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

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Comparison of Number of Participants With Implant Passing - Test to Reference	1 Participants	1 Participants

SECONDARY outcome

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

Population: Data analyzed "as treated."

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.

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety	0 Participants	0 Participants

SECONDARY outcome

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

Population: Data analyzed "as treated."

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

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Comparison of Incidence of Adverse Events - Test to Reference	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Six-months post-operative and again at 12 months post-operative

Population: Data analyzed "as treated."

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.

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Number of Participants With Non-increase in Dyspareunia at Follow-up	0 Participants	0 Participants

SECONDARY outcome

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

Population: Data analyzed "as treated."

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.

Outcome measures

Measure	Test Article - Zip-stitch Clips n=1 Participants Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - VICRYL Suture n=1 Participants Will not be compared against the test article, but will be performed for reference and safety.
Number of Participants With Non-increase in Pain at Follow-up	1 Participants	1 Participants

Adverse Events

Test Article - Zip-stitch Clips

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Reference Group - Vicryl Suture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Article - Zip-stitch Clips n=1 participants at risk Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly-p-dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.	Reference Group - Vicryl Suture n=1 participants at risk Performed for reference and safety.
Reproductive system and breast disorders Cuff cellulitis	100.0% 1/1 • Number of events 1 • One year No differences. As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.	0.00% 0/1 • One year No differences. As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.

Additional Information

Director of Clinical Affairs

ZSX Medical, LLC

Phone: 617-631-8865

Email: info@zsxmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60