Clinical trial NCT04752670: ConMed Beamer Study
Official title: Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Neoplasms
Achalasia
Gastroparesis
Keywords: Endoscopic Submucosal Dissection
Per-Oral Endoscopic Myotomy (POEM)
Gastric Per-Oral Endoscopic Myotomy (G-POEM)
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: CONMED Corporation
First posted: 2021-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for an ESD, POEM or GPOEM satisfying all eligibility criteria will be eligible for the study.

Brief summary: This is a prospective registry of all patients who endoscopic submucosal dissection (ESD), per-oral endoscopic myotomy (POEM) and gastric per-oral endoscopic myotomy (G-POEM) using ConMed Electrosurgical unit for submucosal Dissection at Baylor St Luke's Medical Center. Collected information includes; procedure technical success rate, duration, periprocedural complications and ease of use.

Detailed description: Submucosal endoscopy is a novel subset of procedures which enables endoscopist to utilize the submucosal space to perform advanced endoscopic procedures. The submucosa is the third layer of the gastrointestinal wall and it is a potential space which is expandable upon injecting the submucosa with fluid. The expanded submucosa causes a significant lift which enable dissection of the submucosal space with the removal of the overlying polyp or early cancer. The submucosal space can be also utilized to create a longitudinal submucosal tunnel in the esophagus or the stomach wall which allows for performing lower esophageal sphincter or pyloric myotomy for the treatment of achalasia or Gastroparesis.

Currently, the most commonly performed submucosal endoscopy procedures are endoscopic submucosal dissection (ESD) for removal of early cancers or polyps throughout the gastrointestinal tract, Per-oral Endoscopic Myotomy (POEM) for treatment of achalasia, or Gastric Per-Oral Endoscopic myotomy for the treatment of Gastroparesis. All of the above procedures require a specialized electrosurgical unit (ESU) which generate high frequency current to help incision (cutting) of the mucosa and dissection (coagulation) of the submucosa. The ConMed Beamer is a novel ESU with tissue sensing property which expedites the process of submucosal dissection. The device is currently approved for clinical use in the US. The purpose of this study is to create registry for all submucosal endoscopy procedures performed using ConMed Beamer device at BSLMC with focus on clinical outcomes of the procedure including adverse events.

Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years old
* Patient is capable of providing informed consent
* Patient is referred for endoscopic submucosal dissection, per-oral endoscopic myotomy, or gastric per-oral endoscopic myotomy

Exclusion Criteria:

* Patient is \< 18 years old
* Patient refused and/or unable to provide consent
* Patient is a pregnant woman

Primary outcomes:
measure: Technical Success rate
timeFrame: 1 year
Secondary outcomes:
measure: Procedure Time
timeFrame: 1 year
measure: Adverse Events
timeFrame: 1 year
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor St. Lukes Medical Center (BSLMC)
state: Texas
Study officials:
References: