The Captivator EMR Registry

Completed

• Conditions: Barrett's Esophagus

• Registration Number: NCT02482701
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-26
• Study Start: 2015-08
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of resections per procedure	Procedure	The number of resection per procedure is assessed during the EMR Procedure
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.
Ability to endoscopically manage complications without the need for additional interventions	Procedure	Endoscopic management of complications is assessed during the EMR procedure
Accessory devices used during the procedure for complication management	Procedure	Accessory device use 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.

Trial Locations

Locations (12)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University Hospital Leuven; 🇧🇪 Leuven, Belgium

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Krankenhaus Barmherzige Bruder; 🇩🇪 Regensburg, Bavaria, Germany

EVK Krankenhaus; 🇩🇪 Dusseldorf, Germany

Academic Medical Center; 🇳🇱 Amsterdam, AZ, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, EJ, Netherlands

St. Antonius Hospital; 🇳🇱 Nieuwgein, NL, Netherlands

Erasmus MC - University Medical Center; 🇳🇱 Rotterdam, Netherlands

Addenbrookes Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

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