Trans-nasal Endoscopy for Bariatric Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Christopher C. Thompson, MD, MSc
Study ID
NCT06200961
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Transnasal Endoscopy — DEVICE
    Unsedated endoscopic evaluation through the nose.
  • Esophagogastroduodenoscopy — PROCEDURE
    Sedated endoscopic evaluation through the mouth.

Study Details

This study plans to learn if the EvoEndo Endoscopy system can be used to evaluate, provide and follow up care for upper gastrointestinal tract diseases in the bariatric population. The smallest current scope available for such a technique is an adult transnasal endoscope with a larger diameter, a pulmonary bronchoscope or Ear Nose and Throat (ENT) laryngoscope. This study is evaluating a newly Food and Drug Administration (FDA) cleared ultra-slim, single-use, endoscope specifically designed for transnasal endoscopy to evaluate its use in adult upper tract gastrointestinal diseases. If such a technique is successful it could improve the safety, cost, and access of endoscopic care for patients in need of an endoscopic evaluation for a bariatric medical condition.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Transnasal Endoscopy (TNE)
    Unsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope.
  • Active Comparator: Sedated Esophagogastroduodenoscopy (EGD)
    Sedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope.

Primary Outcome Measure

Experience survey [ Time Frame: Up to 7 days post procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Michele B. Ryan, MS
[email protected]
6175258266
Christopher C. Thompson, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MA

Related Studies