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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

C-Scan System

About this trial

This is an interventional diagnostic trial for High Risk (Above Average) Subjects

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

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

1st degree relatives of CRC subjects Alternatively average risk based on their age and demographics referred for screening for polyps.

Exclusion Criteria:

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)
Concurrent participation in another clinical trial using any investigational drug or device

Sites / Locations

Rambam Medical Center
Haemek Medical Center
Soroka Medical Center
Bnai-Zion Medical Center
Meir Medical Center
Laniado Medical Center
Tel Aviv Sorasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High risk subjects

Average risk

Arm Description

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:

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Number of polyp specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm detected by the capsule system in various segments of the colon as

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

Using the C-Scan View work station, the review will determine the score, on a scale of 1-10, the completeness of the colon model in each case. The average and Standard Deviation [SD] of all results will be calculated

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

Each case will be reviewed by 3 independent reviewers who are blinded to the results of the FIT and colonoscopy. Calculate the variance between the results of each reviewer

Full Information

NCT ID

NCT03356002

First Posted

November 20, 2017

Last Updated

February 6, 2020

Sponsor

Check-Cap Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03356002

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 28, 2018 (Actual)

Primary Completion Date

January 26, 2020 (Actual)

Study Completion Date

January 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Check-Cap Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

Detailed Description

The subject will be invited to come to the clinic to sign the Informed Consent Form [ICF] and other related . The subjects will be connected to the C-Scan Track and following system's activation the subject will be asked to ingest the C-Scan Capsule with some water and contrast media, in the presence of a physician. Post ingestion, the subject will be discharged home with clear instructions on the procedure. The subject should avoid intensive physical exercise during procedure or any extreme activities. The subject should make an effort to stay at home or other familiar surroundings, and may continue daily activities such mobile/computer/Television use, shower, sleep or eat. Details on allowed and restricted activities are listed in app. 4 The subject will be required to ingest daily dose (3 X 15-17ml) of contrast media, to be consumed three times per day with normal diet. Also on a need based the subject would be provided with laxadine (5 mg tablets) to be ingested according to the doctor recommendation. During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team (or by dedicated external trained medical personnel), to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress. Subjects may be also monitored by the technical team (either at home or at the clinic), who may need to examine the system or inquire the subjects about the system visual/auditory indicators. The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion. Capsule procedure is completed upon capsule excretion or system vibro/auditory indication of 'End of Procedure'. Once the procedure is completed, The C-Scan Capsule and C-Scan Track will be collected from the subject and returned to the sponsor's lab for preliminary analysis. All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure. C-Scan Procedure Analysis: Several (3-6) licensed gastroenterologist physicians, will be trained with reviewing and analyzing C-Scan System scans, to serve as independent reviewers. Each case will be reviewed by 3 independant reviewers. The reviewing forum will be blinded to the FIT and colonoscopy results of the examined patients. Analysis will be performed on a per patient basis for the existence or non-existence of a finding that may be a polyp. This per patient finding will be compared with the FIT, and a colonoscopy will be performed for verification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Masking Description

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

Allocation

Non-Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High risk subjects

Arm Type

Active Comparator

Arm Description

Arm Title

Average risk

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

C-Scan System

Other Intervention Name(s)

Colon capsule

Intervention Description

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. To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy To evaluate the safety of the C-Scan Capsule System procedure

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

One year

Secondary Outcome Measure Information:

Title

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

Description

Number of polyp specificity of C-Scan Capsule System in detecting patients with polypoid lesions 6≤x≤9 mm detected by the capsule system in various segments of the colon as

Time Frame

One year

Title

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

Description

Time Frame

One year

Title

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

Description

Each case will be reviewed by 3 independent reviewers who are blinded to the results of the FIT and colonoscopy. Calculate the variance between the results of each reviewer

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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 1st degree relatives of CRC subjects Alternatively average risk based on their age and demographics referred for screening for polyps. Exclusion Criteria: 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) Concurrent participation in another clinical trial using any investigational drug or device

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boaz Shpigelman

Organizational Affiliation

VP R&D

Official's Role

Study Director

Facility Information:

Facility Name

Rambam Medical Center

City

Haifa

State/Province

North

Country

Israel

Facility Name

Haemek Medical Center

City

Afula

Country

Israel

Facility Name

Soroka Medical Center

City

Be'er Sheva

Country

Israel

Facility Name

Bnai-Zion Medical Center

City

Haifa

Country

Israel

Facility Name

Meir Medical Center

City

Kfar Saba

Country

Israel

Facility Name

Laniado Medical Center

City

Netanya

Country

Israel

Facility Name

Tel Aviv Sorasky Medical Center

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Preliminary results will be presented in the European Gastro Week Conference [UEGW] on October 2018

Learn more about this trial

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

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