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NCT06245577: BioSynIRS
Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP
NA trial testing interdisciplinary mesh sacro colpopexy with resection rectopexy in Intestinal Obstruction in 30 participants. Participants enrolled and being followed up; not accepting new ones.
31 October 2024
Quick facts
| Lead sponsor | Evangelisches Klinikum Köln Weyertal gGmbH |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 30 January 2024 |
| Primary completion | 31 October 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- interdisciplinary mesh sacro colpopexy with resection rectopexy
Conditions studied
- Intestinal Obstruction — all drugs for Intestinal Obstruction →
- Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
- Rectal Prolapse — all drugs for Rectal Prolapse →
Sponsor
Evangelisches Klinikum Köln Weyertal gGmbH
Who can join
Adults 18 to 80, female only, with Intestinal Obstruction or Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the pilot study is to demonstrate the safety and efficacy of a biological mesh compared to a standard synthetic mesh for the planned procedure in the above-mentioned clinical picture. Subsequently, a multicentre, randomized intervention study is planned to confirm the results and evaluate the long-term outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06245577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Intestinal Obstruction
Currently open trials in the same condition.
- NCT07432542 — Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery · NA · active not recruiting
Other Evangelisches Klinikum Köln Weyertal gGmbH trials
Trials by the same sponsor.
- NCT06502184 — Mental Health Outcome After Surgery for Obstructed Defecation Syndrome (ODS) · completed
- NCT05910021 — Early Safety of Resection Recopy and Sacrocolpopexy · completed
- NCT05016700 — Neuropathological Changes of the Intestinal Wall in Patients With Bowel Evacuation Disorders · recruiting
- NCT04573075 — Ghost Ileostomy (GI) Versus Loop Ileostomy (LI) After Colorectal Resections · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06245577 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Evangelisches Klinikum Köln Weyertal gGmbH
- Last refreshed: 18 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06245577.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing