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NCT03991455
Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
NA trial testing Apyx device in Pelvic Organ Prolapse in 17 participants. Completed in 1 May 2022.
1 May 2022
Quick facts
| Lead sponsor | Escala Medical LTD |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 25 October 2019 |
| Primary completion | 1 May 2022 |
| Estimated completion | 1 May 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Apyx device
Conditions studied
- Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
Sponsor
Escala Medical LTD
Who can join
Adults 18 to 90, female only, with Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to further evaluate this minimally invasive SSLF technique with respect to safety, clinical effectiveness, and patient satisfaction. The procedure will be performed in women electing to undergo surgical repair of their prolapse who wish to preserve their uterus, and will be evaluated using standardized measures and questionnaires.
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 NCT03991455
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pelvic Organ Prolapse
Currently open trials in the same condition.
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- NCT07104292 — Pelvic Floor Muscle Training During Pregnancy · NA · recruiting
- NCT07218016 — The AccelERate Trial · NA · recruiting
- NCT07114029 — VNOTES Approach in Mesh Free Sacrocolpopexy: A Functional and Anatomic Evaluation · NA · recruiting
- NCT07082023 — Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques · NA · recruiting
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 NCT03991455 (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 Escala Medical LTD
- Last refreshed: 27 July 2022
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/NCT03991455.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing