Barrett's Esophagus
Conditions
Keywords
EMR, EAC, Barrett's Neoplasia, Multiband Mucosectomy
Brief summary
To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.
Interventions
DEVICECaptivator™ EMR
The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years. 2. 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. 3. Subject is scheduled for endoscopic resection of present neoplasia 4. Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy. 5. Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage). 6. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.
Exclusion criteria
1. Subject 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 or radiotherapy. 2. Presence of esophageal stenosis preventing passage of a therapeutic gastroscope. 3. Endoscopically visible scarring by any cause of the intended treatment zone. 4. Esophageal varices. 5. Subject has known or suspected esophageal perforation. 6. Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure. | Procedure | Successful resection is assessed during the EMR procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedure time | Procedure | Total procedure time is assessed during the EMR procedure |
| Seriousness and severity of adverse events related to the Captivator™ EMR device or procedure | Procedure through 30 days post EMR procedure | Study subjects will have follow-up visits after the EMR procedure during which the occurrence of adverse events related to the Captivator EMR procedure or device will be assessed. These visits will occur at the following time points: * Immediately following the EMR procedure (Post procedure evaluation) * 48 hour telephone call * 30 day telephone call * Unscheduled clinic visits will be performed in-between protocol required follow-up, as necessary. Once the 30 day phone call is complete, the subject will have completed the study. |
| Accessory devices used during the procedure for complication management | Procedure | Accessory device use is assessed during the EMR procedure |
| Number of resections per procedure | Procedure | The number of resection per procedure is assessed during the EMR Procedure |
| Accessory devices used to complete the resection procedure | Procedure | Accessory devices used to complete resection is assessed during the EMR procedure |
| Histopathology | Post Procedure | Histopathology of resection specimens is performed per standard of practice at each participating study center. Results are expected within approximately 7 days of the EMR procedure. |
| Ability to endoscopically manage complications without the need for additional interventions | Procedure | Endoscopic management of complications is assessed during the EMR procedure |
Countries
Belgium, Canada, Germany, Netherlands, United Kingdom, United States
Outcome results
None listed