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

Overview

About this study

The purpose of this study is 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Eligibility last updated 6/30/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Shabana Pasha, M.D.

Contact us for the latest status

Contact information:

Jourdan Richardson

(480) 301-4226

Richardson.Jourdan@mayo.edu

More information

Publications

Publications are currently not available