Laparoscopic Hysterectomy
Conditions
Brief 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).
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.
Interventions
DEVICEZip-stitch(TM)
The assigned intervention is used to close the cuff following colpotomy.
Sponsors
ZSX Medical LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint - Number of Participants With Implant Passing | Six-weeks post-operative | Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks |
| Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence | Six-weeks post-operative | Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Number of Participants With Implant Passing - Test to Reference | evaluated at six months post-operative | Percentage of subjects experiencing implant passing will be compared between test and reference groups |
| Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety | Evaluated after one week, six week, six month, and twelve month follow-up | 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. |
| Number of Participants With Successful Vaginal Cuff Closure | Performed at one week, six weeks, and six months after surgery; reported here at six weeks | Binary, visual surgeon cuff closure evaluation |
| Number of Participants With Non-increase in Dyspareunia at Follow-up | Six-months post-operative and again at 12 months post-operative | 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. |
| Number of Participants With Non-increase in Pain at Follow-up | Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase | 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. |
| Comparison of Incidence of Adverse Events - Test to Reference | Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time | Adverse events and serious adverse events will be tabulated for both the test and reference groups. |
| Number of Participants With Vaginal Cuff Healing | Performed at one week, six weeks, and six months after surgery; reported here at six weeks | Binary, visual surgeon cuff healing evaluation |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Reference Group - Vicryl Suture Will not be compared against the test article, but will be performed for reference and safety. | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Test Article - Zip-stitch Clips | Total | Reference Group - Vicryl Suture |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 3 | 43 years STANDARD_DEVIATION 3 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 64.5 inches STANDARD_DEVIATION 3.5 | 64.5 inches STANDARD_DEVIATION 3.5 | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 164.5 pounds STANDARD_DEVIATION 39.5 | 164.5 pounds STANDARD_DEVIATION 39.5 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
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
Population: Data analyzed as-treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Primary Efficacy Endpoint - Number of Participants With Implant Passing | 0 Participants |
| Reference Group - VICRYL Suture | Primary Efficacy Endpoint - Number of Participants With Implant Passing | 1 Participants |
Primary
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
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence | 0 Participants |
| Reference Group - VICRYL Suture | Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence | 0 Participants |
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.
Time frame: Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Comparison of Incidence of Adverse Events - Test to Reference | 1 Participants |
| Reference Group - VICRYL Suture | Comparison of Incidence of Adverse Events - Test to Reference | 0 Participants |
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
Time frame: evaluated at six months post-operative
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Comparison of Number of Participants With Implant Passing - Test to Reference | 1 Participants |
| Reference Group - VICRYL Suture | Comparison of Number of Participants With Implant Passing - Test to Reference | 1 Participants |
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.
Time frame: Six-months post-operative and again at 12 months post-operative
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Number of Participants With Non-increase in Dyspareunia at Follow-up | 0 Participants |
| Reference Group - VICRYL Suture | Number of Participants With Non-increase in Dyspareunia at Follow-up | 0 Participants |
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.
Time frame: Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Number of Participants With Non-increase in Pain at Follow-up | 1 Participants |
| Reference Group - VICRYL Suture | Number of Participants With Non-increase in Pain at Follow-up | 1 Participants |
Secondary
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
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Number of Participants With Successful Vaginal Cuff Closure | 1 Participants |
| Reference Group - VICRYL Suture | Number of Participants With Successful Vaginal Cuff Closure | 0 Participants |
Secondary
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
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Number of Participants With Vaginal Cuff Healing | 1 Participants |
| Reference Group - VICRYL Suture | Number of Participants With Vaginal Cuff Healing | 0 Participants |
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.
Time frame: Evaluated after one week, six week, six month, and twelve month follow-up
Population: Data analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Article - Zip-stitch Clips | Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety | 0 Participants |
| Reference Group - VICRYL Suture | Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety | 0 Participants |