Health TrialsbyHealthPanel

Trans-nasal Endoscopy for Bariatric Patients

ConditionsObesityObesity, MorbidObeseGI DisordersGastrointestinal Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChristopher C. Thompson, MD, MSc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient 18 years of age and less than 90 years of age with clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD)

Cared for in metabolic and bariatric clinic

Disqualifiers

Patient <18 years of age

Medically contraindicated to perform EGD or TNE

Inability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transnasal Endoscopy

    Device

    Unsedated endoscopic evaluation through the nose.

  • Esophagogastroduodenoscopy

    Procedure/Surgery

    Sedated endoscopic evaluation through the mouth.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Transnasal Endoscopy (TNE)Active comparator 1 intervention
Group B: Sedated Esophagogastroduodenoscopy (EGD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Experience survey

Evaluate the experience of patients and provider teams utilizing sedation-free transnasal endoscopy for evaluation of upper gastrointestinal (GI) conditions

Time frame
Up to 7 days post procedure

Secondary outcomes

1

Patient interest

Assess the number of subjects who are asked versus enroll in the study

Time frame
Baseline
2

Patient satisfaction - mGHAA-9

Satisfaction of subjects undergoing unsedated TNE using the EvoEndo Endoscopy System via the modified Group Health Association of America-9 survey (mGHAA-9)

Time frame
Up to 7 days post procedure
3

Patient satisfaction - TNE Post-procedure evaluation

satisfaction of subjects undergoing unsedated TNE using the EvoEndo Endoscopy System via the Post Procedure Unsedated Transnasal Endoscopy Instrument

Time frame
Up to 7 days post procedure
4

Duration of procedure

Assess duration in minutes of TNE (nose in/nose out)

Time frame
Up to 7 days post procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christopher C. Thompson, MD, MSc

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

EvoEndo, Inc.

Collaborator

Source ClinicalTrials.gov
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