Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264466
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-09
Brief Title:
Safety and Efficacy of a Novel Flexible Bipolar in POEM
Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Organization:
Instituto Ecuatoriano de Enfermedades Digestivas
Study Overview
Official Title:
Safety and Efficacy of the Novel Speedboat UltraSlim With Radiofrequency and Microwave Ablation Flexible Biplolar for Per-Oral Endoscopic Myotomy in Patients With Achalasia A Single Center Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 promises 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
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 promises 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
Detailed Description:
Achalasia is characterized by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter LES to relax To date the therapies with higher success rates are the Heller myotomy and the minimally invasive per-oral endoscopic myotomy POEM Different tools have been developed for the different POEM stages mucosal incision submucosal tunneling myotomy and closure However some devices need exchanging accessories for cutting and coagulation
In light of the above the investigators aim to evaluate a newly launched ultra-slim flexible catheter Speedboat Ultraslim Creo Medical UK that integrates bipolar radiofrequency RFA energy and microwave in its tip for cutting and coagulation respectively in patients with achalasia Some proposed advantages of using this device during POEM are 1 less inflammation and better healing process derived from localized bipolar energy 2 a protective full that facilities clear differentiation between muscular and mucosal layers 3 the use of a single device to complete the POEM procedure
After completing the inclusion criteria the patients with achalasia will undergo POEM anterior or posterior incision with or without fundoplication F-POEM The procedures will be performed by previously trained expert endoscopist The mucosal incision submucosal tunneling and cutting will be performed using RFA energy while coagulation will be performed with microwave both integrated in the tip of the Ultraslim Speedboat
Technical and clinical success along with safety will be the primary outcomes while post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index RSI along with endoscopic and pH studies and the Northwestern Esophageal Quality of Life NEQOL respectively
In light of the above the investigators aim to evaluate a newly launched ultra-slim flexible catheter Speedboat Ultraslim Creo Medical UK that integrates bipolar radiofrequency RFA energy and microwave in its tip for cutting and coagulation respectively in patients with achalasia Some proposed advantages of using this device during POEM are 1 less inflammation and better healing process derived from localized bipolar energy 2 a protective full that facilities clear differentiation between muscular and mucosal layers 3 the use of a single device to complete the POEM procedure
After completing the inclusion criteria the patients with achalasia will undergo POEM anterior or posterior incision with or without fundoplication F-POEM The procedures will be performed by previously trained expert endoscopist The mucosal incision submucosal tunneling and cutting will be performed using RFA energy while coagulation will be performed with microwave both integrated in the tip of the Ultraslim Speedboat
Technical and clinical success along with safety will be the primary outcomes while post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index RSI along with endoscopic and pH studies and the Northwestern Esophageal Quality of Life NEQOL respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None