An Endoscopic Barbed-clips Suturing for Colorectal ESD
A Novel Endoscopic Barbed-clips Suturing for Mucosal Defect Closure After Endoscopic Submucosal Dissection of Colon
1 other identifier
interventional
35
1 country
2
Brief Summary
Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. After ESD procedure, endoscopists close the defects with devices to prevent complications. A novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. In this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after ESD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2021
CompletedSeptember 16, 2021
September 1, 2021
2 months
August 17, 2021
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The technical success rate
Rate of completely closure of the ESD defect
1 day
Secondary Outcomes (3)
Endoscopic barbed-clips suturing closure time
1 day
Rate of patients reported with bleeding/perforation post-ESD procedure
7 days
Clips used post-ESD
7 days
Study Arms (1)
Endoscopic Barbed-clips Suturing
EXPERIMENTALPatients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing.
Interventions
Endoscopic Barbed-clips Suturing
Eligibility Criteria
You may qualify if:
- aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for ESD;
You may not qualify if:
- Patients with coagulopathy (platelet count \< 5 × 10\*4, prothrombin time international normalized ratio \> 2,
- medical conditions requiring the continuous use of antithrombotic agents
- prior abdominal surgery or radiation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071, China
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Pei Deng, Dr.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2021
First Posted
September 16, 2021
Study Start
September 20, 2021
Primary Completion
December 1, 2021
Study Completion
December 20, 2021
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share