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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05042947
Other study ID # DLCT-1.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2022

Study information

Verified date January 2022
Source Ningbo No. 1 Hospital
Contact Lei f Xu
Phone +8613486659126
Email xulei22@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Studies have shown that postoperative inflammation can be relieved by clipping the wound, and can reduce the bleeding rate and perforation rate.Scholars at home and abroad have proposed the use of adhesives and circular surgical lines to clamp the wound.In 2019, Satoshi Abiko and others proposed the use of double-loop clips technology to clamp the wound, and make double-loop clips of appropriate length outside the body.Therefore, our study is a prospective randomized controlled study to explore whether the double-loop clips technique is safe and effective for larger wounds in daily clinical work.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients with wounds larger than 20mm - Patients aged 18 to 75 years old Exclusion Criteria: - Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv. - Pregnant or breastfeeding. - Allergy or intolerance to any study drug. - Patients who have taken anticoagulant drugs (aspirin, clopidogrel, etc.) in the past week but are contraindicated for endoscopic polyp treatment. - Other imaging findings suggest patients with advanced cancer. - Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon

Study Design


Related Conditions & MeSH terms


Intervention

Device:
double-loop clips
a new ligation method using the double-loop clips (D-L clips) technique
Titanium Clip
the Titanium Clip

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 complete closure rate Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when there was no remaining visible mucosal defect and clips were <1cm apart. 1 hour
Secondary Operating time The time from when the first clip is hit until it is completely closed 1 hour
Secondary Closing speed Resection area divided by clamping time 1 hour
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