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van CCT (UK)


PreCap-study


- candidate number22484
- NTR NumberNTR5286
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2015
- Secondary IDs2015_043 METC AMC
- Public TitlePreCap-study
- Scientific TitleEfficacy and safety of a new EMR device for early neoplasia in the Barrett’s esophagus
- ACRONYMPreCap
- hypothesisEndoscopic resection of Barrett's neoplasia with the Captivator EMR device is effective and safe
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus , Endoscopic resection
- Inclusion criteriaPhase I
1.Age 18-80 years
2.Subject is scheduled for esophagectomy
3.Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.

Phase II
1.Age 18-80 years
2.Barrett’s esophagus with a visible abnormality and biopsy-proven high grade dysplasia and/or early cancer
3.Lesion with a maximum size of 4 cm in longitudinal length and 50% of the circumference.
4.No suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography
5.No signs of lymph node and/or distant metastasis on endosonography and CT-scanning of the thorax and abdomen.
6.Patient is scheduled for endoscopic resection of present BE neoplasia
7.Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.
- Exclusion criteriaPhase I
1.Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
2.Presence of esophageal stenosis limiting access to the intended treatment zone.
3.Scarring by other causes of the intended treatment zone.
4.Subject refuses or is not able to provide written informed consent.

Phase II
1.Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
2.Presence of esophageal stenosis limiting access to the intended treatment zone.
3.Scarring by any cause of the intended treatment zone.
4.Subject refuses or is not able to provide written informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-jul-2015
- planned closingdate20-jan-2016
- Target number of participants11
- InterventionsPhase I:
Endoscopic resection with Captivator EMR device and with Duette EMR device (currently used EMR device) of esophageal tissue prior to esophagectomy

Phase II:
Endoscopic resection of Barrett's neoplasia with Captivator EMR device
- Primary outcomePhase I
1)Maximum diameter of the resection specimens retrieved with the CaptivatorTM -and DuetteTM devices.

Phase II
1)Percentage of successful endoscopic resection (i.e. resection of all lesion delineation markings)
- Secondary outcomePhase I
1)Difference in the number of device or procedure related complications, such as bleeding or perforation, experienced with the CaptivatorTM device compared to the DuetteTM device.
2)Visibility of the CaptivatorTM device and the DuetteTM device (pre- and post-procedure).
3)Ease of endoscopic resection
4)Procedure time

Phase II
1)Number and severity of any acute (during procedure) or early (0-48 hours) device or procedure related complications such as bleeding or perforation during endoscopic resection with the CaptivatorTM device. Complications are registered only if they are clinically significant.
2)Presence of any late complications (> 48 hours) such as bleeding or perforation during endoscopic resection with the CaptivatorTM device. Complications are registered only if they are clinically significant.
3)Procedure time
- TimepointsPhase I
Time 0: studyendoscopy prior to esophagectomy. After completion of studyendoscopy: end of study

Phase II
Time 0: treatment endoscopy
Time 2 (after 48 hours): telephone call
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESResearch fellow Kamar Belghazi
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.G.H.M. Bergman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Boston Scientific
- Publications
- Brief summaryRationale: Endoscopic resection (ER) is the core modality in endoscopic therapy for early esophageal neoplastic lesions (i.e. high grade dysplasia [HGD] or early carcinoma) in Barrett’s esophagus (BE). Histopathological assessment of the resection specimen provides the opportunity to select patients suitable for further endoscopic treatment with additional ER or ablative therapy. Recently, a new MultiBand Mucosectomy (MBM) device (CaptivatorTM EMR, Boston Scientific Corporation, Natick, MA, USA) has been developed which may have advantages over the current MBM device (DuetteTM, Cook Medical, Limerick, Ireland) by improved visualization, passage of accessories, and suction power due to different trigger cords and cap. Objective: The aim of this study is to assess the safety and efficacy of the new CaptivatorTM EMR device.
Study design: This study will be executed in two phases. Phase I of this study is a prospective randomized trial comparing the CaptivatorTM EMR and the DuetteTM MBM device for which 3-6 patients will be included; phase II is a prospective pilot series with the CaptivatorTM EMR for which 5 patients will be included.
Study population: For phase I adult male and female patients scheduled for esophagectomy will be included. For phase II adult male and female BE patients with known early esophageal neoplastic lesions scheduled for endoscopic resection will be included.
Intervention (if applicable): In phase I, ERs with the CaptivatorTM and DuetteTM device will be performed directly pre-esophagectomy in the upper healthy part of the esophagus. In phase II, all ERs will be performed with the CaptivatorTM EMR device instead of the DuetteTM device.
Main study endpoints: For phase I the primary outcome is the maximum diameter of the resection specimens retrieved with the CaptivatorTM EMR- and DuetteTM devices. For phase II the primary outcome is the percentage of successful endoscopic resections (i.e. resection of all lesion delineation markings).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In phase I, the additional risk with participation is related to the longer sedation time. Patients will not be exposed to significant device associated complications because all the study patients will directly undergo an esophagectomy after the ER procedure. In phase II, patients will undergo a MBM procedure. Since the new CaptivatorTM EMR device is very similar to the current DuetteTM device, no additional risks for the MBM procedure are expected.
- Main changes (audit trail)
- RECORD20-jul-2015 - 19-aug-2015


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