Pelvic Organ ProlapsePhase 4NCT06263985
Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.
A Phase 4 study testing Axis Dermis biologic mesh repair for pelvic organ prolapse in people with Pelvic Organ Prolapse, run by Michigan Institution of Women's Health PC at 1 site in United States.
Trial 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]. Read more about this study
- Who is it for?
- Ages 21 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Axis Dermis biologic mesh repair for pelvic organ prolapse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 30 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Urogynecology of Michigan
Dearborn, Michigan, 48124
About this study
Official title: Prospective Analysis of Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.
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.
Read the 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
- Being tested
- Axis Dermis biologic mesh repair for pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axis Dermis biologic mesh repair for pelvic organ prolapseDevice
Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Axis Dermis biologic mesh repair for pelvic organ prolapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Preoperative to 3 years postoperative.
Secondary outcomes (1)
Assess complications or untoward side effects.
Assessment of intraoperative complications (such as bleeding and injuries) and post operative complications (such as de novo incontinence, de novo dyspareunia, recurrent urinary tract infections, voiding dysfunction and effect on untreated vaginal wall).
Measured: intraoperative to 3 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start2 Nov 2021
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan Institution of Women's Health PC
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Responsible party
- Principal investigator, Salil Khandwala, Michigan Institution of Women's Health PC
- Investigators
- Salil Khandwala, MD, Principal investigator, Michigan Institution of Women's Health PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263985
- Sponsor's protocol ID
- 20214133
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.
- ClinicalTrials.gov ID
- NCT06263985
- Acronym / sponsor ID
- 20214133
- Conditions
- Pelvic Organ Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Michigan Institution of Women's Health PCUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh.
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh | Other | Device: Axis Dermis biologic mesh repair for pelvic organ prolapseThis 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. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axis Dermis biologic mesh repair for pelvic organ prolapseSubjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh. | Device | Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh |
Primary outcome
Improvement in function
Time frame: Preoperative to 3 years postoperative.
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.
Improvement in Anatomy
Time frame: Preoperative to 3 years postoperative.
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.
1 secondary outcome
Assess complications or untoward side effects.
Time frame: intraoperative to 3 years postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salil Khandwala, MD principal investigator
Michigan Institution of Women's Health PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Axis Dermis biologic mesh repair for pelvic organ prolapse in people with Pelvic Organ Prolapse, run by Michigan Institution of Women's Health PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in function (time frame: Preoperative to 3 years postoperative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.