ConMed Beamer Study
Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Start
First participant enrolled
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMay 27, 2022
May 1, 2022
9 months
February 9, 2021
May 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical Success rate
Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system
1 year
Secondary Outcomes (3)
Procedure Time
1 year
Adverse Events
1 year
Adverse Events
1 year
Eligibility Criteria
All patients referred for an ESD, POEM or GPOEM satisfying all eligibility criteria will be eligible for the study.
You may qualify if:
- 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
You may not qualify if:
- Patient is \< 18 years old
- Patient refused and/or unable to provide consent
- Patient is a pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- CONMED Corporationcollaborator
Study Sites (1)
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 12, 2021
Study Start
May 27, 2021
Primary Completion
March 2, 2022
Study Completion
May 1, 2022
Last Updated
May 27, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
This is a prospective single-center registry study.