WithdrawnNot Applicable

Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)

Stopped: Study was cancelled by sponsor due to priority realignment

0Started 2024-05-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult male and female subjects (≥18 years)
✓. 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).
✓. The subject received an explanation and understands the nature of the study and provided oral consent.

What they're measuring

Prospective collection of PillCamTM SB3 capsule endoscopy and DAE procedures data

Timeframe: Up to 3 years from study approval

Trial details

NCT IDNCT05450393

SponsorMedtronic - MITG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04-30

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