Disposable Endoscope Platform in Third Space Endoscopic Procedures

NCT06738628 | Not Yet Recruiting

• 1 other identifier: H-55176
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achalasia; Gastroparesis

Keywords

Per-Oral Endoscopic Myotomy; Gastric Per-Oral Endoscopic Myotomy; Disposable Endoscope

Outcome Measures

Primary Outcomes (1)

• Technical Success

  Defined as the ability to perform entire myotomy (procedure) with the disposable endoscope.

  Day 1 (procedure day)

Secondary Outcomes (4)

• Total Procedure Time

  During Procedure

• Intraprocedural adverse events

  During Procedure

• Satisfactory scores on Endoscopist satisfaction

  Immediately following completion of the procedure

• Scores on musculoskeletal strain survey

  Immediately following completion of the procedure

Interventions

(Esophageal or Gastric) Per-Oral Endoscopic Myotomy PROCEDURE

Performing Per-Oral Endoscopic Myotomy for the treatment of either achalasia of the esophagus, or gastroparesis of the stomach.

Also known as: POEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Patient is ≥ 18 years old.
• Patients can provide informed consent.
• Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia; Gastroparesis

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Othman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Othman, MD

CONTACT

7137980950; Mohamed.Othman@bcm.edu

Fares Ayoub, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: December 17, 2024
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)