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ConMed Beamer Study

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ClinicalTrials.gov Identifier: NCT04752670
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
ConMed Corporation
Information provided by (Responsible Party):
Mohamed Othman, Baylor College of Medicine

Study Description
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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.

Condition or disease
Gastrointestinal Neoplasms Achalasia Gastroparesis

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : March 25, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Technical Success rate [ Time Frame: 1 year ]
    Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system


Secondary Outcome Measures :
  1. Procedure Time [ Time Frame: 1 year ]
    Determine length of time to perform procedure using ConMed Beamer electrosurgical system

  2. Adverse Events [ Time Frame: 1 year ]
    Intraprocedural AE such as bleeding or perforation

  3. Adverse Events [ Time Frame: 1 year ]
    Post procedural, post polypectomy, delayed bleeding or delayed perforation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752670


Contacts
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Contact: Michael Mercado 7137983606 Michael.Mercado@bcm.edu

Locations
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United States, Texas
Baylor St. Lukes Medical Center (BSLMC) Recruiting
Houston, Texas, United States, 77030
Contact: Mohamed O. Othman, MD    713-798-0950    Mohamed.Othman@bcm.edu   
Contact: Michael Mercado    7137983606    Michael.Mercado@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
ConMed Corporation
More Information
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Responsible Party: Mohamed Othman, M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04752670    
Other Study ID Numbers: H-49160
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a prospective single-center registry study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Othman, Baylor College of Medicine:
Endoscopic Submucosal Dissection
Per-Oral Endoscopic Myotomy (POEM)
Gastric Per-Oral Endoscopic Myotomy (G-POEM)
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations
Neoplasms by Site
Neoplasms