Rectal ProlapseNCT04130555
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
An observational study of Rectal Prolapse, run by Meccellis Biotech at 3 sites in France.
Trial summary
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Dec 2019to 26 Oct 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Constitution and follow-up of a consecutive cohort of patients operated with the CELLIS Rectopexy membrane based on the usual practices, the indication and the inclusion-exclusion criteria.
Who may be able to join
- Patient aged ≥18 years,
- Patient with an indication of rectal prolapse repair by ventral rectopexy (external and internal rectal prolapse),
- Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- Patient being informed of the porcine origin of the device in advance of the procedure.
Who cannot join
- Patient with known hypersensitivity to porcine materials,
- Patient with an existing infection not appropriately treated,
- Patient who are pregnant,
- Patient having refused to participate to the study,
- Patient refusing to come back to the follow-up visits.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Estaing
Clermont-Ferrand, 63 003
CHU Nantes Hôtel Dieu
Nantes, 44 093
Hôpital Haut-Lévèque- CHU de Bordeaux
Pessac, 33 604
About this study
Official title: Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
Read the detailed description
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of CELLIS Rectopexy used in rectal prolapse repair by ventral rectopexy.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 55 patients scheduled for the repair of rectal prolapse.
Each patient will participate in one assessment period including a screening visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits at Day 30 (+/- 7 days), Month 6 (+/- 2 weeks), Month 12 (+/- 2 weeks) and Month 24 (+/-2 weeks).
The surgical technique used to repair rectal prolapse will be either Laparoscopic Ventral Rectopexy (LVR) or a robotic assisted rectopexy with the use of the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA).
- Conditions
- Rectal Prolapse
- Being tested
- CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
- Keywords
- ventral rectopexy, biological mesh
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)Device
Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy
| Study group | Role | What they receive |
|---|---|---|
| CELLIS Rectopexy | Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix Receives: Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events including reoperation and removal of the mesh
Percentage
Measured: From the surgical procedure through the entire 24-month follow-up period
Secondary outcomes (9)
Rate of structural defect recurrence based on rectal examination with/without adjunctive investigations as clinically indicated
Percentage
Measured: Throughout the study until end of the 24-month follow-up period
Rate of structural defect recurrence requiring reoperation
Percentage
Measured: Throughout the study until end of the 24-month follow-up period
Symptoms evolution: presence or absence of symptoms (constipation, fecal incontinence, bloody and/or mucous rectal discharge (soiling), unsatisfactory sexual activity, pain)
Described at each visit and compared to baseline
Measured: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Symptoms severity scored by a visual analog scale (0-10; 0 corresponding to no impact on life and 10 corresponding to extreme, incapacitating impact)
Described at each visit and compared to baseline
Measured: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Rate of symptoms recurrence
Percentage
Measured: Throughout the study until end of the 24-month follow-up period
Severity of disease by the use of the Cleveland Clinic Incontinence Score (CCIS)
Change from screening of total score at each follow-up visit. This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).
Measured: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Severity of disease by the use of the Obstructed Defecation Score (ODS)
Change from screening of total score at each follow-up visit. The ODS score is the sum of all points, with a minimum of 0 point and a maximum possible of 31 points with higher scores meaning worse outcome.
Measured: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Quality of life by the use of the Short Form (36) Health Survey (SF-36) questionnaire
Change from screening of each domain score and total score at 24-month. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 with lower scores = more disability, and higher scores = less disability
Measured: At baseline and at 24-month
Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.
Summarized and listed
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start11 Dec 2019
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meccellis Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guillaume MEURETTE, MD, Principal investigator, CHU Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130555
- Sponsor's protocol ID
- RPR_01_CIP
- Other IDs
- 2019-A02024-53 (ID-RCB)
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2019
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy
- ClinicalTrials.gov ID
- NCT04130555
- Acronym / sponsor ID
- RPR_01_CIP
- Conditions
- Rectal Prolapse
- Keywords
- ventral rectopexy, biological mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Meccellis BiotechIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 17 Oct 2019 (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 general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
Detailed description
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of CELLIS Rectopexy used in rectal prolapse repair by ventral rectopexy.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 55 patients scheduled for the repair of rectal prolapse.
Each patient will participate in one assessment period including a screening visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits at Day 30 (+/- 7 days), Month 6 (+/- 2 weeks), Month 12 (+/- 2 weeks) and Month 24 (+/-2 weeks).
The surgical technique used to repair rectal prolapse will be either Laparoscopic Ventral Rectopexy (LVR) or a robotic assisted rectopexy with the use of the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CELLIS Rectopexy | – | Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Constitution and follow-up of a consecutive cohort of patients operated with the CELLIS Rectopexy membrane based on the usual practices, the indication and the inclusion-exclusion criteria.
Key inclusion criteria (4 listed)
- Patient aged ≥18 years,
- Patient with an indication of rectal prolapse repair by ventral rectopexy (external and internal rectal prolapse),
- Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- Patient being informed of the porcine origin of the device in advance of the procedure.
Key exclusion criteria (5 listed)
- Patient with known hypersensitivity to porcine materials,
- Patient with an existing infection not appropriately treated,
- Patient who are pregnant,
- Patient having refused to participate to the study,
- Patient refusing to come back to the follow-up visits.
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 |
|---|---|---|
| CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy | Device | CELLIS Rectopexy |
Primary outcome
Rate of adverse events including reoperation and removal of the mesh
Time frame: From the surgical procedure through the entire 24-month follow-up period
Percentage
9 secondary outcomes
Rate of structural defect recurrence based on rectal examination with/without adjunctive investigations as clinically indicated
Time frame: Throughout the study until end of the 24-month follow-up period
Rate of structural defect recurrence requiring reoperation
Time frame: Throughout the study until end of the 24-month follow-up period
Symptoms evolution: presence or absence of symptoms (constipation, fecal incontinence, bloody and/or mucous rectal discharge (soiling), unsatisfactory sexual activity, pain)
Time frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Symptoms severity scored by a visual analog scale (0-10; 0 corresponding to no impact on life and 10 corresponding to extreme, incapacitating impact)
Time frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Rate of symptoms recurrence
Time frame: Throughout the study until end of the 24-month follow-up period
Severity of disease by the use of the Cleveland Clinic Incontinence Score (CCIS)
Time frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Severity of disease by the use of the Obstructed Defecation Score (ODS)
Time frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Quality of life by the use of the Short Form (36) Health Survey (SF-36) questionnaire
Time frame: At baseline and at 24-month
Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.
Time frame: During the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Guillaume MEURETTE, MD principal investigator
CHU Nantes, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Prolapse, run by Meccellis Biotech at 3 sites in France.
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 4 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: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of adverse events including reoperation and removal of the mesh (time frame: From the surgical procedure through the entire 24-month follow-up period). 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 27 Oct 2023.