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NCT02861391
Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.
NA trial testing CO2 AcuPulse Laser in Exposure Laser in 125 participants. Completed in 30 January 2022.
1 November 2021
Quick facts
| Lead sponsor | Rambam Health Care Campus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 4 October 2019 |
| Primary completion | 1 November 2021 |
| Estimated completion | 30 January 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- CO2 AcuPulse Laser
- Sham Laser
Conditions studied
- Exposure Laser — all drugs for Exposure Laser →
Sponsor
Rambam Health Care Campus — full company profile →
Who can join
Adults 18 to 70, female only, with Exposure Laser. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.
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 NCT02861391
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CO2 AcuPulse Laser
Trials testing the same drug.
- NCT02847897 — Evaluation of Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Vaginal Elasticity. · NA · completed
Other Rambam Health Care Campus trials
Trials by the same sponsor.
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- NCT06235749 — Administration Of Calcium Gluconate for The Reduction of Blood Loss During Elective Cesarean Delivery · NA · recruiting
- NCT06622902 — Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants. · NA · recruiting
- NCT05922111 — Cervical Ripening Balloon for 12 Hours vs. 1 Hour. · NA · not yet 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 NCT02861391 (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 Rambam Health Care Campus
- Last refreshed: 17 January 2023
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/NCT02861391.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing