Last reviewed · How we verify
NCT06264466
Safety and Efficacy of a Novel Flexible Bipolar in POEM
NA trial testing POEM with Speedboat Ultraslim in Esophageal Achalasia in 73 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Instituto Ecuatoriano de Enfermedades Digestivas |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 1 December 2023 |
| Primary completion | 1 December 2024 |
| Estimated completion | 15 January 2025 |
| Sites | 1 location across Ecuador |
Drugs / interventions tested
- POEM with Speedboat Ultraslim
Conditions studied
- Esophageal Achalasia — all drugs for Esophageal Achalasia →
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas — full company profile →
Who can join
Adults 18 to 90, any sex, with Esophageal Achalasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM. To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure. This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06264466
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Related trials
Other recruiting trials for Esophageal Achalasia
Currently open trials in the same condition.
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- NCT06405412 — Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM) · recruiting
- NCT04578769 — Assessment of Different Modified POEM for Achalasia · NA · recruiting
Other Instituto Ecuatoriano de Enfermedades Digestivas trials
Trials by the same sponsor.
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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 NCT06264466 (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 Instituto Ecuatoriano de Enfermedades Digestivas
- Last refreshed: 20 February 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/NCT06264466.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing