ClinicalTrials.gg
Status unknownNCT05042947Updated Jan 13, 2022

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

An interventional study of double-loop clips and Titanium Clip in Polyps and Closure; Delay, sponsored by Ningbo No. 1 Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Polyps
  • Closure; Delay

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03

In context

Polyps

389 studies on the registry are indexed under Polyps; 59 are open to participants now.

This study's planned enrollment of 56 is below the median of 160 across 253 interventional studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 59 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with wounds larger than 20mm
  • Patients aged 18 to 75 years old

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    DLCT

    After finding polyps that meet the inclusion criteria, the surgical method for resection was selected according to the operator's preferences, and the experimental group used double-loop coil clamp technology to treat the wound.

    Device: double-loop clips

  • Active comparator
    Traditional technology

    After finding polyps that meet the inclusion criteria, the surgical method for resection was selected according to the operator's preferences.The control group used the traditional hemostatic clip technique to treat the wound

    Device: Titanium Clip

Interventions

  • Devicedouble-loop clips

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

  • DeviceTitanium Clip

    the Titanium Clip

    Also known as: Traditional technology

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

Secondary outcomes

  1. Operating time

    The time from when the first clip is hit until it is completely closed

    Time frame: 1 hour

  2. Closing speed

    Resection area divided by clamping time

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
  • Ningbo first hospital
    Ningbo, Zhejiang 315000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05042947
Lead sponsor
Ningbo No. 1 Hospital
Responsible party
Sponsor
First posted
Sep 13, 2021
Start date
Oct 1, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jan 13, 2022

Study contacts

Lei f Xu
Contact
xulei22@163.com
+8613486659126

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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