Clinical trial · Observational
The Captivator EMR Registry
An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus
NCT02482701CI-TRIAL-00031983completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Captivator™ EMR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure.
- timeFrame
- Procedure
- description
- Successful resection is assessed during the EMR procedure
Secondary outcomes (7)
- measure
- Number of resections per procedure
- timeFrame
- Procedure
- description
- The number of resection per procedure is assessed during the EMR Procedure
- measure
- Total procedure time
- timeFrame
- Procedure
- description
- Total procedure time is assessed during the EMR procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDPouw 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. PMID 30220300