NCT03608930

Brief Summary

This clinical trial is being conducted to assess whether the rotary polypectomy snare could decrease the time to removal of colorectal polyps

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 12, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2018

Enrollment Period

1 day

First QC Date

July 12, 2018

Last Update Submit

June 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • the average time of each polyp removing

    Using a stopwatch to record the removing time of each polyp (starting the stopwatch when the snare stretched out of the pipe and ending with the polyp being completely removed); Furthermore, we excluded the time of submucosal injection, electrocoagulation, and the use of preventive titanium clips

    1day

Secondary Outcomes (1)

  • Postpolypectomy bleeding

    2 weeks

Other Outcomes (1)

  • The procedure time

    1day

Study Arms (2)

rotary polypectomy snare

EXPERIMENTAL

All colorectal polyps found are removed using a rotary polypectomy snare (Disposable Polypectomy Snare). The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the direction of the snare by rotating the handle as required, rotate the loop until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then inhaling the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is used after hot snare polypectomy if removing a flat polyp or bleeding on the wound after treatment.

Device: Disposable Polypectomy Snare,JHY-SD-23-230-30-A1

regular polypectomy snare

NO INTERVENTION

All colorectal polyps found are removed using a regular polypectomy snare (polypectomy snare, symmetrical). The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the bending section angulation of the colonoscopy as required, advance the snare until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is performed after hot snare polypectomy if a flat polyp or bleeding on the wound after treatment.

Interventions

The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the direction of the snare by rotating the handle as required, rotate the loop until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then inhaling the transected polyp into a trap followed by submission to the histological evaluation.

rotary polypectomy snare

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year;
  • Patients with colorectal polyps ;
  • informed consent;

You may not qualify if:

  • patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure;
  • known coagulopathy;
  • history of inflammatory bowel diseases;
  • Hemodynamically unstable;
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

Study Officials

  • Lei XU, PHD

    Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

August 1, 2018

Study Start

August 1, 2018

Primary Completion

August 2, 2018

Study Completion

September 30, 2018

Last Updated

July 2, 2019

Record last verified: 2018-07

Locations