The Captivator EMR Registry

Barrett's Esophagus Clinical Trial

Official title:

An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482701
• Other study ID #: 91038126
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: March 6, 2018
• Start date: August 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• Captivator™ EMR
The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Canada	St. Michael's Hospital	Toronto	Ontario
Germany	EVK Krankenhaus	Dusseldorf
Germany	Krankenhaus Barmherzige Bruder	Regensburg	Bavaria
Netherlands	Academic Medical Center	Amsterdam	AZ
Netherlands	Catharina Hospital	Eindhoven	EJ
Netherlands	St. Antonius Hospital	Nieuwgein	NL
Netherlands	Erasmus MC - University Medical Center	Rotterdam
United Kingdom	Addenbrookes Hospital	Cambridge	Cambridgeshire
United Kingdom	University College Hospital	London
United Kingdom	Nottingham Digestive Disease Centre, NIHR	Nottingham
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure.	Successful resection is assessed during the EMR procedure	Procedure
Secondary	Number of resections per procedure	The number of resection per procedure is assessed during the EMR Procedure	Procedure
Secondary	Total procedure time	Total procedure time is assessed during the EMR procedure	Procedure
Secondary	Seriousness and severity of adverse events related to the Captivator™ EMR device or 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.	Procedure through 30 days post EMR procedure
Secondary	Accessory devices used during the procedure for complication management	Accessory device use is assessed during the EMR procedure	Procedure
Secondary	Ability to endoscopically manage complications without the need for additional interventions	Endoscopic management of complications is assessed during the EMR procedure	Procedure
Secondary	Accessory devices used to complete the resection procedure	Accessory devices used to complete resection is assessed during the EMR procedure	Procedure
Secondary	Histopathology	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.	Post Procedure