Clinical Trial of Portable Endoscope Medical device
Not Applicable
Completed
- Conditions
- Health Condition 1: K00-K95- Diseases of the digestive system
- Registration Number
- CTRI/2021/12/038633
- Lead Sponsor
- HCL TECHNOLOGIES LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Adults, 18 years of age or older
Subjects with a history of dyspepsia, dysphagia, or lump in the throat.
Subjects with a history of GI bleed.
Subjects with a history of chronic and recurrent abdominal pain.
Subject with a history of gastric ulcers.
Ability to give written informed consent to participate in the study & no history of mental
Illness
Any patient who will undergo upper GI endoscopy for diagnostic purposes and consenting to be involved in the study
Exclusion Criteria
Anyone deemed inappropriate by the researchers or the primary care physician in clinical studies
Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the ease of use of Portable Endoscope system <br/ ><br>To evaluate the Image quality and usage of disposable tube of Portable Endoscope system. <br/ ><br>To evaluate the ease of setting up the screen (smart phone) with the endoscope of Portable Endoscope system <br/ ><br>Timepoint: 60 minutes including pre and post- procedure time
- Secondary Outcome Measures
Name Time Method To evaluate safety of Portable Endoscope systemTimepoint: 60 minutes including pre and post- procedure time