Total Laparoscopic HysterectomyNCT03310658
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
A study testing Zip-Stitch Soft Tissue Closure System in people with Total Laparoscopic Hysterectomy, run by ZSX Medical LLC at 1 site in Mexico.
Trial summary
ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Total Laparoscopic Hysterectomy
- What is being tested?
- Zip-Stitch Soft Tissue Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 17 Apr 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated Informed Consent Form
- Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
- Female, age 18 years or older
- Indicated for Total Laparoscopic Hysterectomy
Who cannot join
- HIV
- Hepatitis C
- Diabetics
- Use of systemic corticosteroids
- History of pelvic irradiation
- Active infection
Show all 10Show fewer
- History of bleeding problems/hemophilia
- Cancer
- Cases in which vaginal cuff closure is intended to be performed robotically
- Pregnant
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey
Monterrey, Nuevo León, 64460
About this study
Official title: Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.
Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.
- Conditions
- Total Laparoscopic Hysterectomy
- Being tested
- Zip-Stitch Soft Tissue Closure System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zip-Stitch Soft Tissue Closure SystemDevice
The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Single Study Site: UANL | Experimental | As the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy. Receives: Device: Zip-Stitch Soft Tissue Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Ease of Use
Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview.
Measured: Immediately following procedure
Secondary outcomes (5)
Vaginal Cuff Closure
Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care.
Measured: During procedure.
Vaginal Cuff Closure Time
Procedural time from uterine excision to successful vaginal cuff closure.
Measured: During Procedure.
Total Surgical Time
Total procedural time.
Measured: During Procedure.
Device Use Learning Curve assessed with a Surgeon Survey
Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.
Measured: Assessed immediately following study completion during surgeon survey.
Sexual Discomfort
Measurement of subject discomfort during sexual activity following completion of surgical procedure. Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).
Measured: Assessed at 1 and 6 week follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start17 Apr 2017
- Primary completion30 Jun 2017
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZSX Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Mazzucco, PhD, Study director, ZSX Medical LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310658
- Sponsor's protocol ID
- ZHP01-1.0
- Status last verified
- Oct 2017
- First submitted
- 26 Sep 2017
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
- ClinicalTrials.gov ID
- NCT03310658
- Acronym / sponsor ID
- ZHP01-1.0
- Conditions
- Total Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ZSX Medical LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.
Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Study Site: UANL | Experimental | Device: Zip-Stitch Soft Tissue Closure SystemAs the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated Informed Consent Form
- Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
- Female, age 18 years or older
- Indicated for Total Laparoscopic Hysterectomy
Key exclusion criteria (10 listed)
- HIV
- Hepatitis C
- Diabetics
- Use of systemic corticosteroids
- History of pelvic irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zip-Stitch Soft Tissue Closure SystemThe novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy. | Device | Single Study Site: UANL |
Primary outcome
Device Ease of Use
Time frame: Immediately following procedure
Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview.
5 secondary outcomes
Vaginal Cuff Closure
Time frame: During procedure.
Vaginal Cuff Closure Time
Time frame: During Procedure.
Total Surgical Time
Time frame: During Procedure.
Device Use Learning Curve assessed with a Surgeon Survey
Time frame: Assessed immediately following study completion during surgeon survey.
Sexual Discomfort
Time frame: Assessed at 1 and 6 week follow-up visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Mazzucco, PhD study director
ZSX Medical LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zip-Stitch Soft Tissue Closure System in people with Total Laparoscopic Hysterectomy, run by ZSX Medical LLC at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Ease of Use (time frame: Immediately following procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.