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Endocuff Adenoma Detection Rate Pilot Study

Primary Purpose

Colorectal Adenoma, Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endocuff attachment
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Adenoma focused on measuring Adenoma, polyp, colonoscopy.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.
  • Ability to understand the nature and requirements of the study and to provide written informed consent.

Exclusion Criteria:

  • Contraindication to undergo standard colonoscopy.
  • Severe active colitis.
  • Known colonic stricture

Sites / Locations

  • Addenbrooke's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Endocuff assisted colonoscopy

Control standard colonoscopy

Arm Description

Endocuff attachment

Standard colonoscopy

Outcomes

Primary Outcome Measures

Proportion of patients with adenomas and cancers detected

Secondary Outcome Measures

Caecal intubation time

Full Information

First Posted
January 3, 2013
Last Updated
January 4, 2013
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01761097
Brief Title
Endocuff Adenoma Detection Rate Pilot Study
Official Title
A Pilot Study to Assess the Role for Endocuff© Assisted Colonoscopy in the Detection of Colonic Cancer and Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon. The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope. The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma, Colorectal Cancer
Keywords
Adenoma, polyp, colonoscopy.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endocuff assisted colonoscopy
Arm Type
Active Comparator
Arm Description
Endocuff attachment
Arm Title
Control standard colonoscopy
Arm Type
Placebo Comparator
Arm Description
Standard colonoscopy
Intervention Type
Device
Intervention Name(s)
Endocuff attachment
Other Intervention Name(s)
ARC endocuff
Intervention Description
Endocuff
Primary Outcome Measure Information:
Title
Proportion of patients with adenomas and cancers detected
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Caecal intubation time
Time Frame
Immediate
Other Pre-specified Outcome Measures:
Title
Caecal intubation rate
Time Frame
immediate
Title
Polyp detection rate
Time Frame
immediate

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme. Ability to understand the nature and requirements of the study and to provide written informed consent. Exclusion Criteria: Contraindication to undergo standard colonoscopy. Severe active colitis. Known colonic stricture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewen Cameron, MBBS
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2OQQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewen Cameron, MBBS
Phone
01223 348718
Email
ewen.cameron@addenbrookes.nhs.uk
First Name & Middle Initial & Last Name & Degree
Rob Mead, MBBS

12. IPD Sharing Statement

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Endocuff Adenoma Detection Rate Pilot Study

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