Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

NCT06263985 | Active Not Recruiting Phase 4 FDA Device

• 1 other identifier: 20214133
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:

• Is the leading edge of the prolapse above the hymen
• Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Improvement in function

  Determine improvement in function based on questionnaire Pelvic Floor Distress Inventory Q#3 "Do you usually have a bulge or something falling out that you can see or fell in the vaginal area?" Answered No, or if Yes: Not at all bothersome.

  Preoperative to 3 years postoperative.

• Improvement in Anatomy

  To assess improvement in anatomy with success defined as the leading edge of the prolapse is above the hymen, and no reintervention (surgery or pessary) for pelvic organ prolapse.

  Preoperative to 3 years postoperative.

Secondary Outcomes (1)

• Assess complications or untoward side effects.

  intraoperative to 3 years postoperative

Study Arms (1)

Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh

OTHER

This is a single are which will be composed of subjects with Stage II or greater pelvic organ prolapse who have agreed to undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh. They will undergo the procedure and be followed for a period of 3 years.

Device: Axis Dermis biologic mesh repair for pelvic organ prolapse

Interventions

Axis Dermis biologic mesh repair for pelvic organ prolapse DEVICE

Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh.

Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with preoperative stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q)
• Subjects who have bothersome vaginal bulge based upon symptoms.
• Subjects who undergo any type of Axis Dermis surgery (anterior, posterior, total, with or without a uterus).

You may not qualify if:

• Subjects who are unable to follow-up.
• Subjects who cannot complete the validated questionnaires.
• Subjects that lack competency of the English language.
• Subjects who decline to be part of the clinical trial.
• Subjects who do not sign an informed consent.

Sponsors & Collaborators

• Michigan Institution of Women's Health PC: lead
• Coloplast A/S: collaborator

Study Sites (1)

Advanced Urogynecology of Michigan

Dearborn, Michigan, 48124, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Salil Khandwala, MD

  Michigan Institution of Women's Health PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Model Details: Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: November 2, 2021
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

US (1)