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NCT04837690 Clinical Trial

UEMR for Medium-sized Pedunculated Colon Polyps

Colon Polyp Clinical Trial

Official title:
The Use of Underwater Endoscopic Mucosal Resection for Medium-sized Pedunculated Colon Polyps: A Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04837690
Other study ID # AUEMR-1.0
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date October 1, 2021

Study information
Verified date April 2021
Source Ningbo No. 1 Hospital
Contact Lei Xu, M.D
Phone +8613486659126
Email xulei22@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 32
Est. completion date October 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Patients age between 18-75 years old with pedunculated colonic polyps (measuring between 10 and 20mm), who willing to participate in this study. Exclusion Criteria: 1. pregnancy, 2. inflammatory bowel disease, 3. familial polyposis 4. the use of anticoagulant therapy or antiplatelet therapy 5. the absence of informed patient consent. 6. Polyps showing signs of deep submucosal invasion

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• UEMR
(1) the colorectal lumen was completed deflated with 500-1000 mL sterile water using a flushing pump; (2) the lesion and 2-3 mm of normal mucosa surrounding the base of the polyp were snared and subsequently resected with an electrosurgical generator

Locations
Country Name City State
China Ningbo First Hospital Ningbo Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The rate of bleeding the bleeding was defined as the active hemorrhage lasted for = 30 s or other condition requires immediate intervention. 1 Day of colonoscopy
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