Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses

NCT03735407 | Completed Results DMC FDA Device

• 1 other identifier: CL-SY-02-0096
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center, Single-arm, safety study Purpose: To demonstrate the safety of the Check-Cap C-Scan System Study Centers: Up to two (2) centers located in the United States Number of Participants: 45 healthy subjects Investigational Device: Check-Cap's C-Scan System comprises C-Scan Capsule, C-Scan Track and C-Scan View. Primary Objective: To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives: a. To evaluate subject's compliance b. To evaluate subject's satisfaction c. To collect data to improve the product's algorithm

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE)

  The safety of the Check-Cap System will be evaluated by the incidence of device and procedure related Serious Adverse Events (SAE), as adjudicated by the Independent Physician Adjudicator.

  6 Months

Secondary Outcomes (2)

• Non-compliance Rate of Subjects (%)

  6 months

• To Evaluate Subject's Satisfaction

  8 weeks

Study Arms (1)

C-Scan procedure

EXPERIMENTAL

Subjects who are at high or at average risk for developing CRC and who are scheduled for optical colonoscopy will undergo C-Scan procedure

Device: C-Scan procedure

Interventions

C-Scan procedure DEVICE

The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion. o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,

Also known as: data collection to improve the product's algorithm

C-Scan procedure

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.
• Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone.
• Subjects able and agrees to undergo colonoscopy procedure.
• BMI \> 22 and ≤ 35.
• Maximum body (abdominal) circumference \< 120 cm.
• Has at least 3 bowel movements per week
• A colonoscopy procedure is pre-scheduled within 60 days

You may not qualify if:

• Known history of dysphagia or other swallowing disorders.
• History of the followings: Inflammatory Bowel Disease (IBD) including Crohn's disease or Ulcerative, Colitis, Meckel's Diverticulum, Bowen Hernia, known fistulas or strictures (doctors' discretion), or a history of small bowel obstruction.
• Known motility disorders:
• i. Chronic Constipation: less than 3 bowel movements/week, w/out the use of laxatives.
• ii. Delayed gastric emptying. iii. Narcotic use d. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion with the exception of appendectomy, cholecystectomy and hysterectomy e. Any condition believed to have an increased risk for capsule retention, strictures, bowel adhesion or other obstacles to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies (e.g. due to obstructions or NSAID enteropathy) as determined by physician discretion.
• f. Has a cardiac device (e.g. pacemaker or ICD-Implantable Cardioverter Defibrillator) or any other active implanted device g. Known sensitivity to iodine, or with known kidney failure. h. Known condition which precludes compliance or is contraindicated with study and/or device instructions.
• i. Has a Magnetic Image Resonance (MRI) procedure scheduled within 1 month j. Known condition of drug abuse and/or alcoholism. k. Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization.
• l. Concurrent participation in another clinical trial using any investigational drug or device.

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (1)

Mayoclinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Clinical Director
• Organization: CheckCap

daniella.bleistein@check-cap.com

972-4-8303401

Study Officials

• Seth Gross

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multi-center, Single-arm, safety study

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 8, 2018
• Study Start: February 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 15, 2020
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Locations

US (1)