Using a new endoscopy technique for bariatric patients
Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program
NA · Brigham and Women's Hospital · NCT06200961
This study is testing a new, less invasive endoscopy method for bariatric patients to see if it can improve safety and reduce costs when checking for stomach and digestive issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06200961 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the EvoEndo Endoscopy system for assessing and managing upper gastrointestinal diseases in bariatric patients. It focuses on transnasal endoscopy (TNE), which allows for a less invasive approach compared to traditional sedated oral endoscopy. The study aims to determine if this ultra-slim, single-use endoscope can improve safety, reduce costs, and enhance access to endoscopic care for patients with obesity-related gastrointestinal conditions. By comparing TNE to standard procedures, the study seeks to address challenges such as delayed diagnoses and high costs associated with traditional endoscopy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who are referred for esophagoscopy or gastroscopy and are receiving care in a metabolic and bariatric clinic.
Not a fit: Patients under 18 years of age or those who are medically contraindicated for endoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the safety and accessibility of gastrointestinal evaluations for bariatric patients.
How similar studies have performed: Previous studies have shown the feasibility of transnasal endoscopy in adult populations, but this specific application in bariatric patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient 18 years of age and less than 90 years of age with clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD) 2. Cared for in metabolic and bariatric clinic Exclusion Criteria: 1. Patient \<18 years of age 2. Medically contraindicated to perform EGD or TNE 3. Inability to provide informed consent
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Christopher C. Thompson, MD, MSc — Brigham and Womens Hospital
- Study coordinator: Michele B Ryan, MS
- Email: mryan@bwh.harvard.edu
- Phone: 617-525-8266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Obesity, Morbid, Obese, GI Disorders, Gastrointestinal Diseases, Transnasal Endoscopy, Esophagogastroduodenoscopy, Upper Endoscopy