The Captivator EMR Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004102
- Jacksonville, Florida: 15-004102
NCT ID: NCT02482701
Sponsor Protocol Number: 91038126
About this study
The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.
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
- Age 18-80 years
- Barrett's esophagus with a visible abnormality confirmed upon prior endoscopy
- A visible abnormality is described as meeting one or more of the following definitions
- Lesion is detected as visible based on white light imaging with any macroscopic appearance according to the Paris Classification and is also endoscopically resectable
- Lesion is detected by narrow band imaging (NBI), but without any other specific characteristics for a visible lesion
- Lesion is confirmed to contain high grade dysplasia and/or carcinoma upon prior biopsy
- Scheduled for endoscopic resection of present neoplasia
- Amenable to Endoscopic Mucosal Resection with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy
- Taking a proton pump inhibitor twice daily 40 mg or equivalent dosage
- Willing to participate, fully understands the content of the informed consent form, and signs the informed consent form
Exclusion Criteria
- Has previously undergone endoscopic therapy for esophageal neoplasia, including (but not limited to)
- Cryospray therapy
- Laser treatment
- Photodynamic therapy
- Endoscopic mucosal resection
- Radiofrequency ablation
- Argon plasma coagulation
- Radiotherapy
- Presence of esophageal stenosis preventing passage of a therapeutic gastroscope
- Endoscopically visible scarring by any cause of the intended treatment zone
- Esophageal varices
- Has known or suspected esophageal perforation
- Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed)
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Cadman Leggett, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Herbert Wolfsen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available