Clinical trial · Interventional
Feasibility of Check-Cap's P1 Capsule System Screening
Feasibility, Multi-center Prospective Study of Check-Cap's P1 Capsule System in Patients Eligible for ColoRectal Cancer [CRC] Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): All trials ojectives were met
Summary
Brief summary (as posted)
Prospective, Single arm, Multi-Center 1. To establish the safety and preliminary efficacy of the Check-Cap System in patients with negative FOBT (Fecal Occult Blood Test) 2. To collect data about the overall imaging of the colon internal surface during the passage of the capsule 3. To develop a correlation map between the imaging of the polyps by optical colonoscopy vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by CT Colonography \[CTC\] (in patients which were referred after positive CTC examination)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyps | — | UNRESOLVED | — |
| ColoRectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The P1 Check-Cap capsule | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- P1 capsule and screening Cscopy
- description
- Male and female patients older than 40 and younger than 75 years old who volunteer for the experiment and qualify with the inclusion / Exclusion criteria. The P1 Check-Cap capsule will be ingested by all participants. After the Capsule test, they will be referred for optical colonoscopy as part of the study
- interventionNames
- Device: The P1 Check-Cap capsule
Primary outcomes (1)
- measure
- safety - transit time (less than 300 hours)
- timeFrame
- after each subject (once the capsule in excreted, typically 30-80 hours)
- description
- To evaluate the safety of the device in terms of total and segmental transit time and to study the effect of the presence of polyps and variable colon dimensions on these parameters. The measured effect is the correlation of the capsule transit time (hours) with the number of polyps and their size (in mm).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female between 40 and 75 years of age. * Subject is generally in good health. * Subject is ready to undergo FOBT or FIT and Colonoscopy. * Subject agrees to sign the informed consent. Exclusion Criteria: * Subject has any known Gastro Intestinal \[GI\] related symptoms, complaints or GI diseases. * Subject is contraindicated from performing colon cleansing (bowel prep.) * Subject has cancer or other life threatening diseases or conditions. * Female subject is pregnant. * Subject underwent any abdominal surgery. * Morbid Obese (BMI \> 40) subject. * Subject has known drug abuse or alcoholism problem. * Subject is under custodial care. * Subject is currently or will be participating in other clinical study within 30 days prior to Check-Cap procedure
References
Publications (0)
Data not yet available