Trial Outcomes & Findings for Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy (NCT NCT05570916)
NCT ID: NCT05570916
Last Updated: 2026-06-12
Results Overview
Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence. Vaginal cuff dehiscence is defined as rupture of the surgical wound requiring surgical re-intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
This will be evaluated through six-weeks post-operative.
Results posted on
2026-06-12
Participant Flow
This study was designed as a staged study. After completion of the first stage of 23 subjects, the study was stopped in preparation for a subsequent study.
Participant milestones
| Measure |
Test Article - Zip-stitch Clips
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 - Suture
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
Baseline characteristics by cohort
| Measure |
Test Article - Zip-stitch Clips
n=13 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- Suture
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 Years
n=9 Participants
|
49 Years
n=27 Participants
|
49 Years
n=267 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Height
|
64 Inches
n=9 Participants
|
64 Inches
n=27 Participants
|
64 Inches
n=267 Participants
|
|
Weight
|
181 Pounds
n=9 Participants
|
181 Pounds
n=27 Participants
|
181 Pounds
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: This will be evaluated through six-weeks post-operative.Population: Data analyzed "as treated."
Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence. Vaginal cuff dehiscence is defined as rupture of the surgical wound requiring surgical re-intervention.
Outcome measures
| Measure |
Test Article - Zip-stitch Clips
n=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Vaginal Cuff Dehiscence Rate
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: This will be evaluated through six weeks post operative.Population: Data analyzed "as treated."
Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure. This endpoint is based upon the rate of spontaneous implant passing events. A single event may be pieces of one or more clips or sutures being spontaneously passed by the patient (i.e., not removed by medical staff). For the primary endpoint, only passing of clips will be counted, but for secondary endpoint, clips or sutures will be counted. When implant passing was reported, subjects were asked to collect and provide passed implants, and an in-person evaluation was performed. This involved a visual cuff closure and healing assessment.
Outcome measures
| Measure |
Test Article - Zip-stitch Clips
n=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Number of Participants With Implant Passing Through Six Weeks
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Performed intra-operatively and at one week, six weeks, and six months after surgeryPopulation: Data analyzed "as treated."
Cuff closure was assessed by a qualified independent blinded evaluator at zero, one, and six weeks, as well as at six months, according to a standardized protocol. Surgeon visual assessment graded vaginal cuffs as closed (Y) or not closed (N).
Outcome measures
| Measure |
Test Article - Zip-stitch Clips
n=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Number of Participants With Successful Vaginal Cuff Closure
Intra-operatively · Six Months
|
12 Participants
|
10 Participants
|
|
Number of Participants With Successful Vaginal Cuff Closure
One Week · Six Months
|
9 Participants
|
2 Participants
|
|
Number of Participants With Successful Vaginal Cuff Closure
Six Weeks · Six Months
|
12 Participants
|
10 Participants
|
|
Number of Participants With Successful Vaginal Cuff Closure
Six Months · Six Months
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Performed at one week, six weeks, and six months after surgeryPopulation: Data analyzed "as treated."
Vaginal cuff healing was visually assessed by a blinded evaluator at one week, six weeks, and six months. Evaluator visual assessment graded vaginal cuffs as healed (Y) or not healed (N), or the evaluator indicated that it was not possible to determine.
Outcome measures
| Measure |
Test Article - Zip-stitch Clips
n=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Number of Participants With Healed Vaginal Cuffs
One Week
|
1 Participants
|
0 Participants
|
|
Number of Participants With Healed Vaginal Cuffs
Six Weeks
|
9 Participants
|
9 Participants
|
|
Number of Participants With Healed Vaginal Cuffs
Six Months
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Evaluated at six weeks and six months post-operativePopulation: 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=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Comparison of Number of Participants With Implant Passing - Test to Reference
Between 6 Weeks and 6 Months
|
3 Participants
|
0 Participants
|
|
Comparison of Number of Participants With Implant Passing - Test to Reference
Between 6 Months and 12 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Evaluated through six-month follow-upPopulation: 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=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Evaluated through six-month follow-upPopulation: 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=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Comparison of Incidence of Adverse Events - Test to Reference
Adverse Events
|
4 Participants
|
4 Participants
|
|
Comparison of Incidence of Adverse Events - Test to Reference
Serious Adverse Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Evaluated through twelve-month follow-upPopulation: Analysis population includes only subjects reporting sexual activity at a given visit. "Number Analyzed" reflects subjects who reported sexual activity at both baseline and the specified post-operative timepoint. 6 Zip-stitch and 5 Reference subjects were evaluable at 6 months; 5 per group at 12 months. The Overall Number Analyzed (7 Zip-stitch, 6 Reference) reflects unique subjects contributing data to at least 1 timepoint.
Dyspareunia will be pre-operatively baselined and assessed at each follow-up timepoint, including any unexpected visits, using the sexual pain and discomfort domain (four questions) from the validated Female Sexual Function Index (FSFI). Individual success is defined as non-increase in dyspareunia from baseline to six months. Data analyzed "as treated".
Outcome measures
| Measure |
Test Article - Zip-stitch Clips
n=7 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
n=6 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Comparison of Change in Dyspareunia
Number of Participants With Increase in Dyspareunia between baseline and 6 months
|
1 Participants
|
0 Participants
|
|
Comparison of Change in Dyspareunia
Number of Participants With Increase in Dyspareunia between baseline and 12 months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Six-months post-operative and again at 12 months post-operativePopulation: Data analyzed "as treated."
Patient pain will be pre-operatively baselined and assessed at each follow-up timepoint, including any unexpected visits, using a validated 11-point numerical rating scale (no pain: 0 - the most pain: 10). Individual success is defined as non-increase in pain between baseline and six months. Fisher's Exact Test will be used to compare this measure between Test and Reference groups.
Outcome measures
| Measure |
Test Article - Zip-stitch Clips
n=13 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
n=10 Participants
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Comparison of Change in Pain
Number of Participants With Increase in Pain between baseline and 6 months
|
0 Participants
|
0 Participants
|
|
Comparison of Change in Pain
Number of Participants With Increase in Pain between baseline and 12 months
|
0 Participants
|
0 Participants
|
Adverse Events
Test Article - Zip-stitch Clips
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Reference Group - Suture
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Article - Zip-stitch Clips
n=13 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 - Suture
n=10 participants at risk
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Surgical Site Infection
|
7.7%
1/13 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
0.00%
0/10 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
Other adverse events
| Measure |
Test Article - Zip-stitch Clips
n=13 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 - Suture
n=10 participants at risk
Will not be comparative against the test article, but will be performed for reference and safety.
|
|---|---|---|
|
Reproductive system and breast disorders
Cellulitis
|
15.4%
2/13 • Number of events 2 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
0.00%
0/10 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Gastrointestinal disorders
Painful defecation
|
7.7%
1/13 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
0.00%
0/10 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/13 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
20.0%
2/10 • Number of events 2 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
15.4%
2/13 • Number of events 2 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Reproductive system and breast disorders
Vaginal Yeast Infection
|
0.00%
0/13 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Infections and infestations
SARS-CoV-2
|
7.7%
1/13 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
0.00%
0/10 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Infections and infestations
Clostridium difficile infection
|
7.7%
1/13 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
0.00%
0/10 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.7%
1/13 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
0.00%
0/10 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/13 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
10.0%
1/10 • Number of events 1 • From enrollment until the end of 12 month follow-up
As per protocol, adverse events are safety data, and are therefore reported on an "as treated" basis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60