An interventional study of POEM with Speedboat Ultraslim in Esophageal Achalasia, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Not applicable, Interventional, and Treatment
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.
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.
143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's planned enrollment of 73 is above the median of 56 across 95 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 39 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants aged 18-years and above, referred to the participating center (IECED) with a diagnosis of achalasia and indication for POEM, POEM procedures will be performed using the Speedboat UltraSlim
Device: POEM with Speedboat Ultraslim
POEM procedures, with or without fundoplication, will be conducted by expert endoscopists who have undergone prior training in the utilization of the ultraslim Speedboat. Incisions, whether anterior or posterior, submucosal tunneling, and myotomy will be performed using the Bipolar Radiofrequency Ablation (RFA) integrated into the device's tip. Additionally, for vessel coagulation, the microwave energy integrated into the device's tip will be employed. Successful myotomy will be confirmed by passage of the endoscope through the esophagogastric junction (EGJ) without restriction.
Technical success of procedure
Successful competition of all the stages of the POEM procedure with passage of endoscope through the EGJ.
Time frame: up tp four hours
Clinical success of procedure
The clinical success of the POEM procedure will be assessed by using the Eckardt score. An Eckardt score of ≤3 will be considered as clinical success.
Time frame: up to one year
Frequency of adverse events attributable to the procedure
Frequency of adverse events attributable to the procedure, based on American Society of Gastrointestinal Endoscopy (ASGE) lexicon.
Time frame: Up to three months
Rate of Gastroesophageal reflux disease
The diagnosis of gastroesophageal reflux disease will be based in one or more of the following criteria: 1. Endoscopic Erosive Esophagitis, LA grade B or above 2. Long segment Barrett´s esophagus 3. Peptic esophageal stricture 4. 24-hour pH study with acid exposure time \>6% For endoscopic and pH study, proton pump inhibitors should be stopped for two to four weeks.
Time frame: Up to one year
Assessment of Gastroesophageal reflux disease severity
The gastroesophageal reflux will be clinically assessed by the reflux symptoms index (RSI). The RSI consists in nine items that assess various symptoms related to GERD. RSI ≥13 related to significant reflux disease.
Time frame: Up to one year
Change in health-related quality of life after POEM
Effect in the Gastroesophageal reflux disease health-related quality of life through the Northwestern Esophageal Quality of Life (NEQOL) scale. NEQOL, a 14-item, single-scale measure of Health-related quality of life (HRQOL), that allows for rapid assessment in a clinical setting.
Time frame: Up to six months
Started Dec 2023 (actual). Primary completion is estimated for Dec 2024, 12 months after the start.
Of 32 interventional studies with no phase under Esophageal Achalasia, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's planned 12 months is below that.
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Instituto Ecuatoriano de Enfermedades Digestivas