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PillCam · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Patients that are indicated for colonoscopy or who are suspected or known to suffer from colonic diseases. |
| Name | Type | Description |
|---|---|---|
| PillCam™ (Capsule Endoscopy) | DEVICE | Medical Device |
Inclusion criteria: * Subject is between the ages of 50-75 years and has an indication to undergo colonoscopy: At least 75% of total cases OR * Subject is 18-50 suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (e.g. rectal bleeding, melena, positive FOB...
PillCam is an investigational capsule endoscopy system being studied for use in colonic diseases. It is designed to evaluate the colon through a capsule-based imaging procedure. The device is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
PillCam is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker symbol MDT. The company is conducting clinical research to evaluate the device for colonic disease assessment.
PillCam is in Phase 3 clinical development. A Phase 3 trial has been completed, which evaluated the PillCam Colon Capsule Endoscopy night procedure in patients with colonic diseases. The investigational device has not yet received regulatory approval.
PillCam has one completed Phase 3 clinical trial registered under NCT00951587, titled "Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure." The study enrolled 49 participants in Germany and evaluated the device in patients with colonic diseases.
PillCam is an investigational device and has not been approved by the FDA. It is currently in Phase 3 clinical development, with one completed trial evaluating its use in colonic diseases. Regulatory approval status has not been established.