Clinical trial NCT02482701: The Captivator EMR Registry
Official title: An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Keywords: EMR
EAC
Barrett's Neoplasia
Multiband Mucosectomy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-26
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Barrett's Esophagus patients with early neoplasia.

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


Eligibility criteria: 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).

Primary outcomes:
measure: Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure.
timeFrame: Procedure
Secondary outcomes:
measure: Number of resections per procedure
timeFrame: Procedure
measure: Total procedure time
timeFrame: Procedure
measure: Seriousness and severity of adverse events related to the Captivator™ EMR device or procedure
timeFrame: Procedure through 30 days post EMR procedure
measure: Accessory devices used during the procedure for complication management
timeFrame: Procedure
measure: Ability to endoscopically manage complications without the need for additional interventions
timeFrame: Procedure
measure: Accessory devices used to complete the resection procedure
timeFrame: Procedure
measure: Histopathology
timeFrame: Post Procedure
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder
state: Bavaria
city: Dusseldorf
country: Germany
facility: EVK Krankenhaus
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: AZ
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: EJ
city: Nieuwgein
country: Netherlands
facility: St. Antonius Hospital
state: NL
city: Rotterdam
country: Netherlands
facility: Erasmus MC - University Medical Center
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: London
country: United Kingdom
facility: University College Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Digestive Disease Centre, NIHR
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jacques Bergman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pouw RE, Beyna T, Belghazi K, Koch AD, Schoon EJ, Haidry R, Weusten BL, Bisschops R, Shaheen NJ, Wallace MB, Marcon N, Heise-Ginsburg R, Gotink AW, Wang KK, Leggett CL, Ortiz-Fernandez-Sordo J, Ragunath K, DiPietro M, Pech O, Neuhaus H, Bergman JJ. A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett's esophagus. Gastrointest Endosc. 2018 Oct;88(4):647-654. doi: 10.1016/j.gie.2018.06.030. Epub 2018 Jul 6.