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After the second surgery, enrollment was stopped for reasons unrelated to the study design or test article.
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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 (V-LOC barbed suture).
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.
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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 - V-Loc Barbed Suture | 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(TM) | Device | The assigned intervention is used to close the cuff following colpotomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint - Number of Participants With Implant Passing | Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks | Six-weeks post-operative |
| Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence | Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure. | Six-weeks post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Vaginal Cuff Closure | Binary, visual surgeon cuff closure evaluation | Performed at one week, six weeks, and six months after surgery; reported here at six weeks |
| Number of Participants With Vaginal Cuff Healing |
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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 (may include TLH, LAVH, robotic assisted vaginal hysterectomy)
Exclusion Criteria:
16. 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
Only female subjects are eligible to participate in this study as it concerns intervention during laparoscopic hysterectomy.
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| Name | Affiliation | Role |
|---|---|---|
| David O Holtz, M.D. | Main Line Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Reference Group - Vicryl Suture | Will not be comparative against the test article, but will be performed for reference and safety. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was stopped after two subjects enrolled
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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 | Mean |
| 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 | Primary Efficacy Endpoint - Number of Participants With Implant Passing | Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks | Data analyzed "as-treated." | Posted | Count of Participants | Participants | Six-weeks post-operative |
|
One year
No differences. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cuff cellulitis | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment | cellulitis of the vaginal cuff |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | ZSX Medical, LLC | 617-631-8865 | info@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 | Mar 6, 2020 | Feb 17, 2022 | Prot_SAP_000.pdf |
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Binary, visual surgeon cuff healing evaluation
| Performed at one week, six weeks, and six months after surgery; reported here at six weeks |
| 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 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 after one week, six week, six month, and twelve 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 after one week, six week, six month, and twelve month follow-up; reported here for all time |
| 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. | Six-months post-operative and again at 12 months post-operative |
| 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. | Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase |
| BG001 | Reference Group - Vicryl Suture | Will not be compared 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 |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| OG001 |
| Reference Group - VICRYL Suture |
Will not be compared against the test article, but will be performed for reference and safety. |
|
|
| Primary | Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence | Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Six-weeks post-operative |
|
|
|
| Secondary | Number of Participants With Successful Vaginal Cuff Closure | Binary, visual surgeon cuff closure evaluation | Data analyzed "as treated." | Posted | Count of Participants | Participants | Performed at one week, six weeks, and six months after surgery; reported here at six weeks |
|
|
|
| Secondary | Number of Participants With Vaginal Cuff Healing | Binary, visual surgeon cuff healing evaluation | Data analyzed "as treated." | Posted | Count of Participants | Participants | Performed at one week, six weeks, and six months after surgery; reported here at six weeks |
|
|
|
| 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 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 after one week, six week, six month, and twelve 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 after one week, six week, six month, and twelve month follow-up; reported here for all time |
|
|
|
| Secondary | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Six-months post-operative and again at 12 months post-operative |
|
|
|
| Secondary | 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. | Data analyzed "as treated." | Posted | Count of Participants | Participants | Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase |
|
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|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Reference Group - Vicryl Suture | Performed for reference and safety. | 0 | 1 | 0 | 1 | 0 | 1 |
|
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