Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse;
• Counselled for therapeutic options and given informed consent for VMR or SCR;
• Counselled for different types of mesh (OviTex or Prolene) and randomisation;
• Written informed consent for randomisation, OviTex implant or Prolene;
• Written informed consent for observational data collection.
Locations
Other Locations
Netherlands
Meander Medisch Centrum
RECRUITING
Amersfoort
Contact Information
Primary
Marije Boom, drs.
ma.boom@meandermc.nl
+ 31 33 850 1716
Backup
Esther Consten, Prof.dr
ecj.consten@meandermc.nl
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 184
Treatments
Active_comparator: Polypropylene mesh
Polypropylene mesh (Prolene, PMN3, Ethicon Inc Johnson \& Johnson, Amersfoort, The Netherlands; weight 78 g/m2)
Experimental: OviTex 1S permanent mesh
OviTex Reinforced BioScaffold, Permanent Polymer composed of ovine (sheep) forestomach extracellular matrix (ECM) and polypropylene.
Related Therapeutic Areas
Sponsors
Collaborators: Health Holland
Leads: Meander Medical Center