Completed

POPA Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Surgisis® Soft Tissue Graft

Device
Who is being recruted

Prolapse+1

+ Pathological Conditions, Signs and Symptoms

+ Pathological Conditions, Anatomical

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorCook Group Incorporated
Last updated: February 15, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.

NCT01827774
Principal SponsorCook Group Incorporated
Last updated: February 15, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ProlapsePathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalPelvic Organ Prolapse

Criteria

3 inclusion criteria required to participate
At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)
POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse
18 exclusion criteria prevent from participating
A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer
Active UTI at the time of the index procedure as determined by urine culture
Active vaginal infection at the time of the index procedure
Age < 18 years
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Peking University People's Hospital

Beijing, ChinaOpen Peking University People's Hospital in Google Maps
CompletedOne Study Center