Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects

NCT03356002 | Completed

• 1 other identifier: CL-SY-01-0094
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochemical Test \[FIT\] in high risk subjects

Conditions

High Risk (Above Average) Subjects; Non Compliant Patients for Colo Rectal Cancer [CRC] Screening; Counterindicated Patients for Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of C-Scan Capsule System in detecting per segment polypoid lesions 10 mm and up as compared with Colonoscopy

  Number of polyps detected by the capsule system in various segments of the colon as compared with the results indicated in the report of the follow-up colonoscopy

  One year

Secondary Outcomes (3)

• Sensitivity and specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm, compared with Optical Colonoscopy

  One year

• Calculation of the score of the C-Scan system to generate a 3D model of the colon

  One year

• Quantify the variance of the Interpretation of the data from the C-Scan System between the reviewers

  One year

Study Arms (2)

High risk subjects

ACTIVE COMPARATOR

Each subject will ingest the C-Scan System capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. Subjects to be enrolled in this study are indicated and scheduled to undergo optical colonoscopy based on the following symptoms or by being classified as higher than average risk based on one or more of the following: c. Surveillance - Significant findings in previous optical colonoscopy d. Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy e. Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy f. Diagnostic - Positive FIT test g. Diagnostic - one or more of the typical symptoms:

Device: C-Scan System

Average risk

EXPERIMENTAL

Each subject will ingest the C-Scan System capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. Average risk based on their age and demographics referred for screening for polyps.

Device: C-Scan System

Interventions

C-Scan System DEVICE

Each subject will ingest the capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy. 1. To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy 2. To evaluate the safety of the C-Scan Capsule System procedure

Also known as: Colon capsule

Average risk; High risk subjects

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at the age of 40-80 years old
• Subject provided signed informed consent
• Subjects to be enrolled in this study are indicated and scheduled to undergo optical colonoscopy based on the following symptoms or by being classified as higher than average risk based on one or more of the following:
• Surveillance - Significant findings in previous optical colonoscopy Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy Diagnostic - Positive FIT test
• Diagnostic - one or more of the typical symptoms:
• abdominal pain Change in bowel habits Anemia or overt bleeding in stool Significant weight loss
• st degree relatives of CRC subjects Alternatively average risk based on their age and demographics referred for screening for polyps.

You may not qualify if:

• Subjects with advanced cancer or other life threatening diseases or conditions
• Subject with known history of dysphagia or other swallowing disorders
• Subject with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory Bowel Disease \[IBD\], Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
• Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
• Subject with known delayed gastric emptying
• Subject with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
• Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy, as determined by physician discretion
• Subject with a cardiac pacemaker or other implanted electro medical device
• Subjects with known sensitivity to iodine, or with kidney failure
• Subjects with morbid obesity (BMI \> 40)
• Subjects with belly / girth circumference \> 125 cm
• Subject with any known condition which precludes compliance with study and/or device instructions
• Subject with known condition of drug abuse and/or alcoholism
• Subject who is unable to undergo colonoscopy or bowel preparation necessary for colonoscopy (based on previous attempts or self-declaration)
• Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (7)

Rambam Medical Center

Haifa, North, Israel

Location

Haemek Medical Center

Afula, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Bnai-Zion Medical Center

Haifa, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Laniado Medical Center

Netanya, Israel

Location

Tel Aviv Sorasky Medical Center

Tel Aviv, Israel

Location

Study Officials

• Boaz Shpigelman

  VP R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The colonoscopists will be blinded to the C-Scan system results and FIT results and the reviewers of C-Scan system results will be blinded to Fit and colonoscopy results
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 29, 2017
• Study Start: January 28, 2018
• Primary Completion: January 26, 2020
• Study Completion: January 26, 2020
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (7)