Disposable Endoscope Platform in Third Space Endoscopic Procedures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaylor College of Medicine
About this trial
This is a prospective, single-arm unblinded study performed at a single tertiary center in the United States. All subjects will receive standard medical care and no experimental interventions are going to be performed. The procedures will be performed by Dr. Mohamed Othman, Dr. Salmaan Jawaid, Dr. Tara Keihanian, and Dr. Fares Ayoub. All patients undergoing third space endoscopic procedures including e-POEM and g-POEM, meeting study inclusion criteria will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approached individually for further discussion about the study and obtaining informed consent.
The goal of this prospective, pilot trial is to demonstrate the efficacy, feasibility, safety, and clinical outcomes of third space endoscopic procedures completed using a disposable endoscope platform.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is ≥ 18 years old.
Patients can provide informed consent.
Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.
Disqualifiers
Patient is < 18 years old.
Patient refused and/or unable to provide consent.
Patient is a pregnant woman.
Trial population
All patients 18 years or older, not pregnant (if a woman), consenting to the study, and presents for an Esophageal POEM, or Gastric POEM will be invited to participate on this study.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
(Esophageal or Gastric) Per-Oral Endoscopic Myotomy
Procedure/SurgeryPerforming Per-Oral Endoscopic Myotomy for the treatment of either achalasia of the esophagus, or gastroparesis of the stomach.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Technical Success
Defined as the ability to perform entire myotomy (procedure) with the disposable endoscope.
Time frame
Day 1 (procedure day)Secondary outcomes
1
Total Procedure Time
Total recorded time to perform procedure using disposable endoscope
Time frame
During Procedure2
Intraprocedural adverse events
Adverse events emerging during procedure
Time frame
During Procedure3
Satisfactory scores on Endoscopist satisfaction
Satisfactory survey: with endoscope maneuverability (1-5 Likert scale; 1 being "strongly disagree" to 5 being "strongly agree"), with endoscope functionality \[insufflation, suction, accessory passage\] (1-5 Likert scale), with endoscope image quality (1-5 Likert scale; 1 being "strongly disagree" to 5 being "strongly agree").
Time frame
Immediately following completion of the procedure4
Scores on musculoskeletal strain survey
Musculoskeletal Strain survey: Focused on Overall strain, wrist strain, shoulders strain, and neck strain
Time frame
Immediately following completion of the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: