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NCT03624764: PROCOL
Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)
NA trial testing Laparostopic promontofixation using surgical glue in Prolapse in 90 participants. Completed in 4 January 2020.
4 October 2019
Quick facts
| Lead sponsor | Clinique Beau Soleil |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 90 |
| Start date | 4 January 2017 |
| Primary completion | 4 October 2019 |
| Estimated completion | 4 January 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Laparostopic promontofixation using surgical glue
- Laparostopic promontofixation using threads
Conditions studied
- Prolapse — all drugs for Prolapse →
Sponsor
Clinique Beau Soleil
Who can join
40 and older, female only, with Prolapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The treatment of gynecological prolapse (organ removal) can be done by laparoscopy or vaginally. Laparoscopy is used in 1 out of 2 cases, but learning is difficult and operation time is long. One of the technical difficulties is related to the sutures to the threads. Some surgeons therefore use a glue to fix prosthetic reinforcements more easily and quickly, but this sizing technique has only been evaluated very little. Our study proposes to compare the technique of suture with the thread at the gluing of the prostheses in order to validate the merits of this new technique
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03624764
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prolapse
Currently open trials in the same condition.
- NCT06679621 — A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas · NA · recruiting
- NCT06430931 — Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery · NA · recruiting
- NCT04410393 — Sacrocolpopexy and Lateral Suspension Operations · active not recruiting
- NCT04072588 — Sacrospinous Ligament Fixation and Lateral Suspension Operations · active not recruiting
Other Clinique Beau Soleil trials
Trials by the same sponsor.
- NCT07473011 — Study of the Effect of Spa Therapy on Insomnia · not yet recruiting
- NCT07398833 — Modulation of Working Memory by an Alternating Magnetic Field in Humans · NA · not yet recruiting
- NCT06486961 — Effect of Walking With Music in Obese People (BeatMove) · NA · recruiting
- NCT04032808 — Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related · unknown
- NCT04647981 — Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test. · 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 NCT03624764 (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 Clinique Beau Soleil
- Last refreshed: 9 February 2021
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/NCT03624764.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing