A New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection

Feasibility of a New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection: a Prospective Randomized Controlled Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05042947

Enrollment

Registered

2021-09-13

Start date

2021-10-01

Completion date

2022-12-31

Last updated

2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closure; Delay, Polyps

Brief 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.

Interventions

DEVICEdouble-loop clips

a new ligation method using the double-loop clips (D-L clips) technique

DEVICETitanium Clip

the Titanium Clip

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
complete closure rate	1 hour	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.

Secondary

Measure	Time frame	Description
Operating time	1 hour	The time from when the first clip is hit until it is completely closed
Closing speed	1 hour	Resection area divided by clamping time

Countries

China

Contacts

Primary ContactLei f Xu

xulei22@163.com+8613486659126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026