NCT03935100

Brief Summary

This study will evaluate the effect of endoscopic clipping of colonic diverticula in treatment of symptoms related to diverticular disease. Half of the participants will undergo colonoscopy without the clipping procedure and half will have colonoscopy with clipping of all visible diverticula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

April 30, 2019

Last Update Submit

March 17, 2023

Conditions

Diverticular Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of diverticula closure

    Number of diverticula pre and post clipping

    12 months

Secondary Outcomes (1)

  • Changes in abdominal symptoms

    12 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

All visible diverticula clipped during index colonoscopy

Procedure: Endoscopic clipping

Control Group

PLACEBO COMPARATOR

5 clips fired at random into colon lumen. No diverticula closed.

Other: Placebo - colonoscopy without clipping

Interventions

Endoscopic clippingPROCEDURE

Endoscopic clips fired to close mucosa over diverticular defects.

Treatment Group
Placebo - colonoscopy without clippingOTHER

Colonoscopy performed, no clipping of diverticula

Control Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed symptomatic diverticular disease (5 or more diverticula)
  • Age range 18-90 years
  • Retains capacity and medically fit for colonoscopy

You may not qualify if:

  • Unable to give informed consent
  • Patients with severe co-morbidities and substance misuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Diverticular Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinded to clipping, undergo same procedure
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 2, 2019

Study Start

September 1, 2019

Primary Completion

March 1, 2023

Study Completion

March 16, 2023

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)