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

NCT ID: NCT06263985

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2025-05-30

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.

Detailed Description

This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis™ Dermis biologic mesh. They will be followed for a period of 3 years. A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy.

Clinical examination including vaginal wall retraction with or without pelvic ultrasound, POP-Q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: OTHER

Axis Dermis biologic mesh repair for pelvic organ prolapse

Intervention Type: DEVICE

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

Interventions

Axis Dermis biologic mesh repair for pelvic organ prolapse

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: collaborator

Michigan Institution of Women's Health PC

OTHER

Sponsor Role: lead

Responsible Party

Salil Khandwala

Medical director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salil Khandwala, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan Institution of Women's Health PC

Locations

Advanced Urogynecology of Michigan

Dearborn, Michigan, United States

Countries

United States

Other Identifiers

20214133

Identifier Type: -

Identifier Source: org_study_id