Clinical trial · Observational
Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)
Prospective Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Procedures Data for Development of an Artificial Intelligence Software System to Apply to Endoscopy Procedures (GPS Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was cancelled by sponsor due to priority realignment
Summary
Brief summary (as posted)
A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Intestinal Ulcer Bleeding | — | UNRESOLVED | — |
| Small Intestine Adenocarcinoma | — | UNRESOLVED | — |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Small Intestine Disease | — | UNRESOLVED | — |
| Small Intestine Obstruction | — | UNRESOLVED | — |
| Small Intestine Polyp | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- PillCam SB procedure and deep enteroscopy (Device-assisted enteroscopy, DAE)
- description
- Subjects with abnormal PillCam SB3 procedure followed by DAE (if performed).
Primary outcomes (1)
- measure
- Prospective collection of PillCamTM SB3 capsule endoscopy and DAE procedures data
- timeFrame
- Up to 3 years from study approval
- description
- Collection of GI pathologies data along with descriptive demographics data for research and development purposes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult male and female subjects (≥18 years) 2. The subject underwent a SOC PillCamTM SB3 CE procedure and is referred to a subsequent DAE procedure(s), as part of the routine care or The subject underwent a SOC PillCamTM SB3 CE procedure (not necessarily followed by a DAE) and abnormal findings were indicated in the CE report (optional). 3. The subject received an explanation and understands the nature of the study and provided oral consent. Exclusion Criteria: 1\. The subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
References
Publications (0)
Data not yet available