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

NCT05450393 | Withdrawn

• 1 other identifier: MDT21042
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Small Intestine Disease; Small Intestine Cancer; Small Intestinal Ulcer Bleeding; Small Intestine Obstruction; Small Intestine Adenocarcinoma; Small Intestine Polyp

Outcome Measures

Primary Outcomes (1)

• Prospective collection of PillCamTM SB3 capsule endoscopy and DAE procedures data

  Collection of GI pathologies data along with descriptive demographics data for research and development purposes.

  Up to 3 years from study approval

Study Arms (1)

PillCam SB procedure and deep enteroscopy (Device-assisted enteroscopy, DAE)

Subjects with abnormal PillCam SB3 procedure followed by DAE (if performed).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who underwent standard of care (SOC) PillCamTM SB3 CE and subsequent DAE procedures or Subjects who underwent SOC PillCamTM SB3 CE procedures only and abnormal findings were indicated in their CE report (optional).

You may qualify if:

• 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.

You may not qualify if:

• \. The subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 8, 2022
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share