Total Laparoscopic Hysterectomy
Conditions
Brief 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. 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.
Interventions
DEVICEZip-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.
Sponsors
ZSX Medical LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* HIV * Hepatitis C * Diabetics * Use of systemic corticosteroids * History of pelvic irradiation * Active infection * History of bleeding problems/hemophilia * Cancer * Cases in which vaginal cuff closure is intended to be performed robotically * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Ease of Use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Cuff Closure | During procedure. | Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care. |
| Vaginal Cuff Closure Time | During Procedure. | Procedural time from uterine excision to successful vaginal cuff closure. |
| Total Surgical Time | During Procedure. | Total procedural time. |
| Device Use Learning Curve assessed with a Surgeon Survey | 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 | 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). |
Countries
Mexico
Outcome results
None listed