Disposable Endoscope Platform in Third Space Endoscopic Procedures

NCT ID: NCT06738628

Last Updated: 2025-08-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2026-03-31

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.

Detailed Description

Over the past decade, therapeutic endoscopy has rapidly progressed giving rise to the fields of third space endoscopy and endoscopic surgery. In the foregut, esophageal per-oral endoscopic myotomy (e-POEM) has become the standard approach for achalasia with level I data supporting its use1. For gastroparesis, randomized clinical trial data 2 now supports gastric POEM (g-POEM) use for refractory cases with promising results particularly in diabetic and post-surgical patients.

Despite the remarkable advances in endoscopic therapy, there has been comparably slower progress in innovation for endoscopic platforms. In fact, current endoscope design is not significantly different from the earliest endoscopes where tip deflection is primarily controlled by rotating dials on the shaft of the endoscope and insufflation and suction are controlled by manual pressure-controlled buttons. Original fiberoptic gastroscopes were designed to facilitate diagnostic use, where the endoscopist manipulates tip-deflection dials using both hands while viewing the intestinal mucosa through a viewer, with an assistant moving the shaft of the endoscope. This same design was then adapted for colonoscopy, and later for duodenoscopy and endoscopic ultrasound. Despite significant progress in image quality, the endoscope remains a heavy device, requiring significant dexterity and musculoskeletal fitness on behalf of the endoscopist to perform endoscopy ergonomically without risking muscle injury. In addition, endoscopes require several supportive devices to function, including a separate water pump, video processor, computer screen and if needed an electrosurgical generator, making the portability of traditional endoscopic platforms quite limited.

More recently, rising concerns about infectious complications from reusable endoscopes have led to the development of several single-use endoscope platforms. A novel disposable endoscope (AMBU single-use disposable gastroscope; AMBU USA, Columbia, Md, USA) was recently approved by the U.S. Food & Drug Administration (FDA) in 2022 for use in humans. This endoscopic platform is designed for single use and comes with several advantages compared to traditional reusable endoscopes. The platform is significantly lighter, with a weight of 650 grams compared to a traditional reusable upper endoscope which weighs approximately 3900 grams. Additionally, the single use platform has a wider depth of field and significantly smaller video processor and built in portable screen. These advantages have led our group to use the endoscope for therapeutic foregut procedures including e-POEM and g-POEM with positive results. The investigators at Baylor College of Medicine most recently published a proof-of-concept experience 3 in using the disposable gastroscope for a case of e-POEM, where the significantly lighter weight of the endoscope allowed easier maneuverability and subjectively lower musculoskeletal strain for the performing endoscopist, with no negative effects on image quality or technical aspects of the procedure.

Before wider adoption, these perceived benefits need to be demonstrated in a larger, prospective trial confirming non-inferiority to historical data from reusable platforms and safety.

Conditions

Achalasia; Gastroparesis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

(Esophageal or Gastric) Per-Oral Endoscopic Myotomy

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

Intervention Type: PROCEDURE

Other Intervention Names

POEM

Eligibility Criteria

Inclusion Criteria

1. Patient is ≥ 18 years old.

2. Patients can provide informed consent.

3. Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.

Exclusion Criteria

1. Patient is < 18 years old.

2. Patient refused and/or unable to provide consent.

3. Patient is a pregnant woman.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Othman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Othman, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Central Contacts

Mohamed Othman, MD

Role: CONTACT

Mohamed.Othman@bcm.edu

7137980950

Fares Ayoub, MD

Role: CONTACT

Facility Contacts

Mohamed O. Othman, MD

Role: primary

Mohamed.Othman@bcm.edu

713-798-0950

Fares Ayoub, MD

Role: backup

Fares.Ayoub@bcm.edu

7137980950

Other Identifiers

H-55176

Identifier Type: -

Identifier Source: org_study_id