Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02575287
• Date of registration: 09/09/2015
• Prospective Registration: No
• Primary sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
• Public title: Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes
• Scientific title: Mucosal and Minimal Injuries Detected Through Digital Chromoendoscopy Using Optical Enhancement System™ Associated to High Definition Plus Optical Magnification in Non Erosive Gastroesophageal Reflux Disease
• Date of first enrolment: September 2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02575287
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

Ecuador

Contacts

• Name: Carlos A Robles-Medranda, MD
• Affiliation: Ecuadorian Institute of Digestive Diseases

Key inclusion & exclusion criteria

Inclusion Criteria:

- Above 18 years old patients

- Who agree to participate in the study

- Patients with reflux symptoms (heartburn and regurgitation), with8 or more points at
the GERD questionnaire and no evidence of ulcerative esophagitis, esophageal
strictures, Barrett's esophagus or any erosive sign according to Los Angeles
classification (Grade A to D) in the upper endoscopy using white light nor I-Scan™

Exclusion Criteria:

- Patients with ulcerative esophagitis, esophageal strictures, Barrett's esophagus or
any erosive sign according to Los Angeles classification (Grade A to D)

- Patients with medical history of any kind of esophagitis (including actinic, caustic
or eosinophilic), achalasia.

- Esophageal varices

- Patients with evidence of cancer or mass lesion in the esophagus

- Protons bump inhibitor consumption for at least 3 weeks before endoscopy

- Inability to discontinue non steroidal anti-inflammatory drugs or aspirin prior to
the study

- Severe uncontrolled coagulopathy

- Gastric lesions (ulcer, polyp, cancer), severe gastroparesis

- Prior history of esophageal or gastric surgery.

- Pregnancy and lactation



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non Erosive Reflux Disease

GERD

Intervention(s)

Device: Optical Enhancement

Device: Optical magnification without Optical enhancement

Device: Optical Enhancement with optical magnification

Primary Outcome(s)

Digital chromoendoscopy and optical magnification in the diagnosis of intrapapillary loops (IPCLs) in esophagus. Number of participants with increased number of IPCLs, dilatation or tortuosity of IPCLs [Time Frame: two months]

Secondary Outcome(s)

Number of patients with increased number, dilatation or tortuosity of the intrapapilary loops on endoscopic image and have a positive biopsy for inflammation of mucosa. [Time Frame: two months]

Number of patients in whom the minimal esophageal changes are diagnosed by the digital chromoendoscopy without using the magnification, or with the magnification without using the digital chromoendoscopy or using both. [Time Frame: two months]

Secondary ID(s)

I-JUN-17-2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors