Comparison of precancerous lesions detection between standard colonoscopy and novel balloon colonoscopy

Not Applicable

Completed

• Conditions: Colorectal cancer; Cancer

• Registration Number: ISRCTN70400953
• Lead Sponsor: Smart Medical Systems Ltd

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30273591 (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-14
• Study Completion: 2017-10-23
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Patients over 50
2. Referred to colonoscopy for screening, following positive Fecal Occult Blood Test (FOBT) testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection)
3. The patient must understand and provide written consent for the procedure

Exclusion Criteria

1. Subjects with inflammatory bowel disease
2. Subjects with a personal history of polyposis syndrome
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy
4. Subjects with diverticulitis or toxic megacolon
5. Subjects with a history of radiation therapy to abdomen or pelvis
6. Pregnant or lactating female subjects
7. Subjects who are currently enrolled in another clinical investigation.
8. Subjects with current oral or parenteral use of anticoagulants
9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
10. Any patient condition deemed too risky for the study by the investigator
11. Previous colonic surgery (except for appendectomy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Adenomas and serrated lesions detection rate: the percentage of subjects with at least one adenoma or serrated lesion found in each of the study groups. Timepoint: up to 14 days following procedure (histology results)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Polyp and adenoma detection: number of polyps and adenomas detected. Timepoint: up to 14 days following procedure (histology results)<br> 2. Procedural times: minutes. Timepoint: During the procedure<br> 3. Safety: number and severity of adverse events. Timepoint: During the procedure, post procedure, during follow-up calls or during unscheduled visits of the subjects<br>