Single-operator Versus Double-operator in Single-Balloon Enteroscopy：a Prospective, Multicenter, Non-inferiority, Randomized Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• age greater than eighteen years;
• Suspected small bowel disease with proposed enteroscopy
Locations
Other Locations
China
Xijing Hospital of Digestive Diseases
RECRUITING
Xi'an
Contact Information
Primary
Shuhui Liang
liangsh@fmmu.edu.cn
86-20-84771536
Backup
Hui Luo
fmmulh@163.com
86-20-84771536
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 206
Treatments
Experimental: pilot group
endoscope and overtube equipped with a balloon are operated by one endoscopist.
Experimental: control group
endoscope is operated by one endoscopist and overtube equipped with a balloon is operated by one assistant
Related Therapeutic Areas
Sponsors
Leads: Shuhui Liang