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Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
NA trial testing C-Scan procedure in Colo-rectal Cancer in 45 participants. Completed in 15 February 2020.
| Lead sponsor | Check-Cap Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 45 |
| Start date | 1 February 2019 |
| Primary completion | 1 January 2020 |
| Estimated completion | 15 February 2020 |
| Sites | 1 location across United States |
Check-Cap Ltd.
Adults 40 to 80, any sex, with Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| C-Scan Procedure | 0 |
Subject compliance will be assessed by \- Non-compliance rate throughout the study via diary completion by the subject Specific questionnaire. completed by remote subject monitoring (via telephone) The rate will be measured in a percentage scale (1-100%) Score less then 50% will be considered as a compliance failure
| Group | Value | 95% CI |
|---|---|---|
| C-Scan Procedure | 40 |
Subject satisfaction will be established by: Designated questionnaire that focuses on patient's impressions regarding tolerance and potential safety concerns, which will be provided to the subjects after the C-Scan procedure and after the colonoscopy procedure. Acceptance criteria was defined as average score \>3.5 (1- low satisfaction to 5- high satisfaction), which represent high satisfaction with the safety and tolerance of the C-scan system. Comparing patient's satisfaction with C-Scan procedure and colonoscopy procedure
| Group | Value | 95% CI |
|---|---|---|
| C-Scan Procedure | 3.42 | ± 1.25 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | C-Scan Procedure |
|---|---|---|
| Abdominal pain, cramps | Gastrointestinal disorders | — |
| Skin irritation | Skin and subcutaneous tissue disorders | — |
| diarrhea / soft stool | Gastrointestinal disorders | — |
| Superficial Phlebitis | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| headache | Nervous system disorders | — |
Data from ClinicalTrials.gov NCT03735407 adverse events section.
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
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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