Barrett's EsophagusNCT02482701
The Captivator EMR Registry
An observational study of Barrett's Esophagus, run by Boston Scientific Corporation at 13 sites in 6 countries.
Trial summary
To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Captivator™ EMR
- Type of treatment
- Medical device
- How many people
- 291 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Aug 2015to Jun 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Barrett's Esophagus patients with early neoplasia.
Who may be able to join
- Age 18-80 years.
- 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.
- Subject is scheduled for endoscopic resection of present neoplasia
Show all 9Show fewer
- Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
- Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage).
- Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.
Who cannot join
- 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.
- Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
- Endoscopically visible scarring by any cause of the intended treatment zone.
- Esophageal varices.
- Subject has known or suspected esophageal perforation.
- Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Netherlands4 sites
Academic Medical Center
Amsterdam, AZ, 1105
Catharina Hospital
Eindhoven, EJ, 5623
St. Antonius Hospital
Nieuwgein, NL, 3435CM
Erasmus MC - University Medical Center
Rotterdam, 3015CE
United Kingdom3 sites
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB20QQ
University College Hospital
London, NW1 2BU
Nottingham Digestive Disease Centre, NIHR
Nottingham, NG7 2UH
United States2 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Rochester, Minnesota, 55905
Germany2 sites
EVK Krankenhaus
Düsseldorf, D-40217
Krankenhaus Barmherzige Bruder
Regensburg, Bavaria, 93049
About this study
Official title: An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus
To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.
- Conditions
- Barrett's Esophagus
- Being tested
- Captivator™ EMR
- Keywords
- EMR, EAC, Barrett's Neoplasia, Multiband Mucosectomy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captivator™ EMRDevice
The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Procedure
Secondary outcomes (7)
Number of resections per procedure
The number of resection per procedure is assessed during the EMR Procedure
Measured: Procedure
Total procedure time
Total procedure time is assessed during the EMR procedure
Measured: Procedure
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.
Measured: Procedure through 30 days post EMR procedure
Accessory devices used during the procedure for complication management
Accessory device use is assessed during the EMR procedure
Measured: Procedure
Ability to endoscopically manage complications without the need for additional interventions
Endoscopic management of complications is assessed during the EMR procedure
Measured: Procedure
Accessory devices used to complete the resection procedure
Accessory devices used to complete resection is assessed during the EMR procedure
Measured: Procedure
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.
Measured: Post Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 291 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Bergman, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482701
- Sponsor's protocol ID
- 91038126
- Status last verified
- Mar 2018
- First submitted
- 15 Jun 2015
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30220300
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT02482701
- Acronym / sponsor ID
- 91038126
- Conditions
- Barrett's Esophagus
- Keywords
- EMR, EAC, Barrett's Neoplasia, Multiband Mucosectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Barrett's Esophagus patients with early neoplasia.
Key inclusion criteria (9 listed)
- Age 18-80 years.
- 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:
- Subject is scheduled for endoscopic resection of present neoplasia
- Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
- Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage).
Key exclusion criteria (6 listed)
- 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.
- Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
- Endoscopically visible scarring by any cause of the intended treatment zone.
- Esophageal varices.
- Subject has known or suspected esophageal perforation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Captivator™ EMRThe Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. | Device | – |
Primary outcome
Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure.
Time frame: Procedure
Successful resection is assessed during the EMR procedure
7 secondary outcomes
Number of resections per procedure
Time frame: Procedure
Total procedure time
Time frame: Procedure
Seriousness and severity of adverse events related to the Captivator™ EMR device or procedure
Time frame: Procedure through 30 days post EMR procedure
Accessory devices used during the procedure for complication management
Time frame: Procedure
Ability to endoscopically manage complications without the need for additional interventions
Time frame: Procedure
Accessory devices used to complete the resection procedure
Time frame: Procedure
Histopathology
Time frame: Post Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 30220300Pouw 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.
Related trials for Barrett's Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
Active, not recruiting
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Barrett's Esophagus
Active, not recruiting
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Bergman, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus, run by Boston Scientific Corporation at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, United Kingdom, United States, Germany, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure. (time frame: Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.