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Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130555
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Meccellis Biotech

Brief 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.

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.


Condition or disease Intervention/treatment
Rectal Prolapse Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)

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).

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CELLIS Rectopexy
Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix
Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Percentage

  2. Rate of structural defect recurrence requiring reoperation [ Time Frame: Throughout the study until end of the 24-month follow-up period ]
    Percentage

  3. 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 ]
    Described at each visit and compared to baseline

  4. 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 ]
    Described at each visit and compared to baseline

  5. Rate of symptoms recurrence [ Time Frame: Throughout the study until end of the 24-month follow-up period ]
    Percentage

  6. 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 ]
    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).

  7. 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 ]
    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.

  8. Quality of life by the use of the Short Form (36) Health Survey (SF-36) questionnaire [ Time Frame: At baseline and at 24-month ]
    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

  9. 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 ]
    Summarized and listed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130555


Contacts
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Contact: Claire CISTERNI, PhD +33 (0)6 68 13 76 26 claire.cisterni@meccellis.com
Contact: Guillaume HOFMANSKI +33 (0)7 61 31 11 33 guillaume.hofmanski@meccellis.com

Locations
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France
CHU Estaing
Clermont-Ferrand, France, 63 003
Contact: Brigitte GILLET    +33 (0)4 73 75 05 32    bgillet@chu-clermontferrand.fr   
Principal Investigator: Anne DUBOIS, MD         
CHU Nantes Hôtel Dieu
Nantes, France, 44 093
Contact: Vincent WYART    +33 (0)2 40 08 49 66    Vincent.WYART@chu-nantes.fr   
Principal Investigator: Guillaume MEURETTE, MD         
Hôpital Haut-Lévèque- CHU de Bordeaux
Pessac, France, 33 604
Contact: Stéphanie GUILLON    +33 (0)5 56 79 58 10    stephanie.guillon@chu-bordeaux.fr   
Principal Investigator: Eric RULLIER, MD         
Sponsors and Collaborators
Meccellis Biotech
Investigators
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Principal Investigator: Guillaume MEURETTE, MD CHU Nantes, France

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Responsible Party: Meccellis Biotech
ClinicalTrials.gov Identifier: NCT04130555    
Other Study ID Numbers: RPR_01_CIP
2019-A02024-53 (ID-RCB) ( Other Identifier: ANSM )
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meccellis Biotech:
ventral rectopexy
biological mesh
Additional relevant MeSH terms:
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Rectal Prolapse
Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse