First clinical study about safety and efficacy of a novel method to secure the visual field using gel during endoscopy
Phase 1
- Conditions
- Patients with gastrointestinal bleeding or inadequate preparation for endoscopy
- Registration Number
- JPRN-UMIN000020101
- Lead Sponsor
- Jichi Medical University
- Brief Summary
This method was used in 17 consecutive patients. Of these 17 patients, gel injection was very effective in 10, effective in 5, slightly effective in 1, and not effective in 1. There were no adverse events associated with this method.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
(A) acute abdomen (B) severe inflammation (C) pregnant woman (D) poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor (E) patient who is judged to be unsuitable for this clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective evaluation of efficacy of this method by the operator after the procedure
- Secondary Outcome Measures
Name Time Method Adverse event related to the method using gel