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| ID | Type | Description | Link |
|---|---|---|---|
| R44HD104539 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Article - Zip-stitch Clips | Experimental | Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy |
|
| Reference Group | Other | Will not be comparative against the test article, but will be performed for reference and safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zip-stitch(R) | Device | Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Cuff Dehiscence Rate | 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. | This will be evaluated through six-weeks post-operative. |
| Number of Participants With Implant Passing Through Six Weeks | 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. | This will be evaluated through six weeks post operative. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Vaginal Cuff Closure | 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). | Performed intra-operatively and at one week, six weeks, and six months after surgery |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Gilman, MD | Main Line Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Unified Women's Clinical Research |
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| Label | URL |
|---|---|
| ZSX Medical website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Reference Group - Suture | Will not be comparative against the test article, but will be performed for reference and safety. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data analyzed "as-treated."
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vaginal Cuff Dehiscence Rate | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | This will be evaluated through six-weeks post-operative. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | subcutaneous laparoscopic port site infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment | Cellulitis of the vaginal cuff |
The study was stopped after enrolling 23 subjects out of a planned 59, so the expected statistical power was not reached. In addition, it was seen that a more objective means to evaluate both "cuff closure" and "cuff healing" was needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Mazzucco | ZSX Medical | 617-631-8865 | dmazzucco@zsxmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2023 | Aug 18, 2025 | Prot_SAP_000.pdf |
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| Reference suture | Device | Standard suture for vaginal cuff closure during laparoscopic hysterectomy |
|
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| Number of Participants With Healed Vaginal Cuffs | 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. | Performed at one week, six weeks, and six months after surgery |
| 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. | Evaluated at six weeks and six months post-operative |
| 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. | Evaluated through six-month follow-up |
| 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. | Evaluated through six-month follow-up |
| Comparison of Change in Dyspareunia | 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". | Evaluated through twelve-month follow-up |
| Comparison of Change in Pain | 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. | Six-months post-operative and again at 12 months post-operative |
| Winston-Salem |
| North Carolina |
| 27103 |
| United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Tidewater Clinical Research | Virginia Beach | Virginia | 23456 | United States |
| Mon Health Medical Center | Morgantown | West Virginia | 26505 | United States |
| BG001 | Reference Group- Suture | Will not be comparative against the test article, but will be performed for reference and safety. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Median | Full Range | Inches |
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| Weight | Median | Full Range | Pounds |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Reference Group | Will not be comparative against the test article, but will be performed for reference and safety. |
|
|
| Primary | Number of Participants With Implant Passing Through Six Weeks | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | This will be evaluated through six weeks post operative. |
|
|
|
| Secondary | Number of Participants With Successful Vaginal Cuff Closure | 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). | Data analyzed "as treated." | Posted | Count of Participants | Participants | Performed intra-operatively and at one week, six weeks, and six months after surgery |
|
|
|
| Secondary | Number of Participants With Healed Vaginal Cuffs | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Performed at one week, six weeks, and six months after surgery |
|
|
|
| Secondary | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Evaluated at six weeks and six months post-operative |
|
|
|
| Secondary | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Evaluated through six-month follow-up |
|
|
|
| Secondary | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Evaluated through six-month follow-up |
|
|
|
| Secondary | Comparison of Change in Dyspareunia | 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". | 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. | Posted | Count of Participants | Participants | Evaluated through twelve-month follow-up |
|
|
|
| Secondary | Comparison of Change in Pain | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Six-months post-operative and again at 12 months post-operative |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 4 |
| 13 |
| EG001 | Reference Group - Suture | Will not be comparative against the test article, but will be performed for reference and safety. | 0 | 10 | 0 | 10 | 4 | 10 |
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| Painful defecation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vaginal Bleeding | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vaginal Yeast Infection | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| SARS-CoV-2 | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Pelvic Pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypertension | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| One Week |
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| Six Weeks |
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| Six Months |
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| Six Weeks |
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| Six Months |
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| Number of Participants With Increase in Dyspareunia between baseline and 12 months |
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| Number of Participants With Increase in Pain between baseline and 12 months |
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