Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
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|ClinicalTrials.gov Identifier: NCT03310658|
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : September 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Total Laparoscopic Hysterectomy||Device: Zip-Stitch Soft Tissue Closure System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study|
|Actual Study Start Date :||April 17, 2017|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||May 30, 2018|
Experimental: Single Study Site: UANL
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.
Device: Zip-Stitch Soft Tissue Closure System
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.
- 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.
- Vaginal Cuff Closure [ Time Frame: During procedure. ]Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care.
- Vaginal Cuff Closure Time [ Time Frame: During Procedure. ]Procedural time from uterine excision to successful vaginal cuff closure.
- Total Surgical Time [ Time Frame: During Procedure. ]Total procedural time.
- Device Use Learning Curve assessed with a Surgeon Survey [ Time Frame: Assessed immediately following study completion during surgeon survey. ]Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.
- Sexual Discomfort [ Time Frame: Assessed at 1 and 6 week follow-up visits. ]Measurement of subject discomfort during sexual activity following completion of surgical procedure. Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310658
|Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey|
|Monterrey, Nuevo León, Mexico, 64460|
|Study Director:||Dan Mazzucco, PhD||ZSX Medical LLC|