CB-17-08 Augmented Endoscopy System for Mucosal Lesion Detection During Colonoscopy for Colon Rectal Cancer.

Colorectal Cancer Clinical Trial

Official title:

Prospective, Randomized, Multicenter, Tandem Study Evaluating the Safety and Effectiveness of the CB-17-08 Augmented Endoscopy System for the Detection of Mucosal Colorectal Polyps in Adult Patients Undergoing Screening or Surveillance Colonoscopy for CRC.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954548
• Other study ID #: CB-17-08/03
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: May 7, 2021

Study information

• Verified date: May 2021
• Source: Cosmo Pharmaceuticals NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the performance of the CB-17-08 to help endoscopists find potential mucosal polyps during the colonoscopy procedure, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard colonoscopy alone: the study will investigate whether the use of the device provides an increase in the number of adenomas per colonoscopy as compared to standard colonoscopy. The study will also evaluate the safety of the CB-17-08, assessing if the use of the system increases the total number of excisions without a commensurate number of adenomas as compared to standard colonoscopy.

Description:

Study procedure: Patients will be randomized (1:1) to one of the arms by an IWRS system. Randomization will be stratified by study endoscopist, to balance the number of patients randomized to either of the study groups (1:1) within the same endoscopist, by age (from to 45 to <65 years old; ≥65 years old) and by reason for colonoscopy (screening, surveillance <3 years from previous colonoscopy, surveillance 3-10 years from previous colonoscopy). Each endoscopist shall not enrol more than 90 patients. The following study visits are foreseen for each patient: Screening Visit A screening visit is performed at the investigational site. During this visit out-patients scheduled for colonoscopy will be informed about the aims, procedures, benefits and possible risks of the study prior to signing the informed consent form for inclusion in the study. Their medical history will be recorded as well as eventual clinical or laboratory examinations according to the local standard of care preparation for a colonoscopy, ) and the date for the colonoscopy procedure to be performed at the investigational site will be scheduled. Tandem Colonoscopy Visit Each eligible patient returns to the clinic to undergo a same-day, back-to-back tandem colonoscopy examination performed by the same experienced endoscopist. The randomized allocation will determine whether patients will undergo standard high-definition white light colonoscopy with CB-17-08 immediately followed by standard high definition white light colonoscopy or standard high definition white light colonoscopy followed by standard high definition white light colonoscopy with CB-17-08. Bowel preparation will be done according to the usual standard of care protocols of the individual sites. The quality of bowel preparation will be assessed during colonoscopy using the Boston Bowel Preparation Scale (BBPS). Sedation according to the sites best experience and standard procedures will be delivered to the patient by the endoscopist or an anaesthesiologist. Subjects' vital signs (blood pressure [BP], hearth rate [HR] and oxygen saturation [SpO2]) will be measured and monitored prior to, during and at the end of the tandem colonoscopy procedure. The endoscopist will be instructed to adhere to their usual withdrawal technique and to spend a minimum of 6 minutes withdrawing and examining the colonic mucosa. Time to reach the caecum and time to withdrawal from caecum to exit will be recorded for each colonoscopy. Clean withdrawal time, i.e. withdrawal time excluding the time spent for procedures or washings (if any), will be recorded. At least 6 minutes of clean withdrawal time will be required for all colonoscopies, in accordance to the current ASGE guideline. Withdrawal time, total procedure time, and time for pauses to allow polypectomies and biopsies to be performed will be recorded. Repeated examination of any of the colon segments (e.g. right colon) in normal modality or in retroflexion is not permitted. Each colorectal polyp detected during the first procedure, as well as each polyp detected during the second procedure, will be immediately removed or biopsied and will be sent to the central histology laboratory for characterization. When a mucosal polyp is detected, its estimated size and morphological appearance according to Paris classification will be reported by the endoscopist on the CRF, as well as the anatomical location inside the colonic districts. On the basis of histological examination, polyps will be categorized according to revised Vienna classification and serrated lesion classification.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients age: =45 years;
• Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy for CRC;
• Willingness to undergo tandem colonoscopies with and without the use of CB-17-08 on the same day and in the same procedural setting;
• Ability to provide written, informed consent and understand the responsibilities of trial participation;

Exclusion Criteria:

• The subject is pregnant or is planning a pregnancy during the study period;
• History of inflammatory bowel disease (IBD);
• History of colon resection;
• History of Familial adenomatous polyposis (FAP) syndrome or of Serrated Polyposis Syndrome (SPS);
• History of overt lower GI bleeding;
• History of colonic stricture;
• History of radiation therapy to the abdomen or pelvis;
• Patients with contraindications to colonoscopy such as presence of acute diverticulitis or toxic megacolon;
• Subjects with particular symptoms (e.g diarrhea) who, per clinical practice, have to undergo random biopsies in the colon. Fecal Occult Blood Test (FOBT) or Fecal Immunochemical Test (FIT) positive patients will not be excluded from the study.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• CB-17-08 CADe
CB-17-08 Augmented Endoscopy System with Computer Aided Detection (CADe) function

Locations

Country	Name	City	State
Italy	ASL Roma 1 (Presidio Nuova regina Margherita)	Roma
United Kingdom	Queen Alexandra Hospital	Cosham
United Kingdom	Oxford University Hospitals	Oxford
United States	Geisinger Medical Center	Danville	California
United States	Ascension St. John's Hospital	Detroit	Michigan
United States	Mayo Clinic Eau Claire	Eau Claire	Wisconsin
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Kansas City VA Medical Center	Kansas City	Kansas
United States	Mayo Clinic La Crosse	La Crosse	Wisconsin
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cosmo Artificial Intelligence-AI Ltd

Countries where clinical trial is conducted

United States,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma miss rate [AMR]	AMR, defined as the number of histologically confirmed adenomas and carcinomas detected during the second colonoscopy divided by the total number of histologically confirmed adenomas and carcinomas detected during the first and second colonoscopy combined.	Day 1
Secondary	Polyp Miss Rate [PMR]	PMR, defined as the number of histologically confirmed polyps detected during the second colonoscopy divided by the total number of histologically confirmed polyps detected during the first plus second colonoscopy combined.; Diminutive (<5 mm) hyperplastic polyps of the rectosigmoid region will not be accounted for in the endpoint analysis.	Day 1