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Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

NCT03939715 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-23

No results posted yet for this study

Summary

Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.

Conditions

  • Pelvic Organ Prolapse

Interventions

BIOLOGICAL

DermaPure®

Surgical intervention using DermaPure®

PROCEDURE

native tissue

Surgical intervention using native tissue

Sponsors & Collaborators

  • Tissue Regenix Ltd

    collaborator INDUSTRY

  • Colorado Pelvic Floor Consultants

    lead INDUSTRY

Principal Investigators

  • James Lukban, DO · Colorado Pelvic Floor Consultants

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-05
Primary Completion
2022-05-05
Completion
2022-05-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03939715 on ClinicalTrials.gov