NCT04837690

Brief Summary

Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

April 7, 2021

Last Update Submit

April 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of bleeding

    the bleeding was defined as the active hemorrhage lasted for ≥ 30 s or other condition requires immediate intervention.

    1 Day of colonoscopy

Study Arms (1)

UEMR

Procedure: UEMR

Interventions

UEMRPROCEDURE

(1) the colorectal lumen was completed deflated with 500-1000 mL sterile water using a flushing pump; (2) the lesion and 2-3 mm of normal mucosa surrounding the base of the polyp were snared and subsequently resected with an electrosurgical generator

UEMR

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients or inpatients requiring polypectomy

You may qualify if:

  • Patients age between 18-75 years old with pedunculated colonic polyps (measuring between 10 and 20mm), who willing to participate in this study.

You may not qualify if:

  • pregnancy,
  • inflammatory bowel disease,
  • familial polyposis
  • the use of anticoagulant therapy or antiplatelet therapy
  • the absence of informed patient consent.
  • Polyps showing signs of deep submucosal invasion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 8, 2021

Study Start

May 1, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations