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Clinical trial to investigate the safety and efficacy of the cryoballon swipe ablation system


- candidate number25460
- NTR NumberNTR6191
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-okt-2016
- Secondary IDsC2 Therapeutics CP-0018
- Public TitleClinical trial to investigate the safety and efficacy of the cryoballon swipe ablation system
- Scientific TitleCLINICAL TRIAL TO EVALUATE SAFETY AND DOSE RESPONSE USING THE C2 CRYOBALLOON SWIPE ABLATION SYSTEM FOR THE TREATMENT OF BARRETT’S ESOPHAGUS
- ACRONYMSwipe - dose escalation
- hypothesis
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus, Barrett's dysplasia, Cryoablation
- Inclusion criteria1. Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
• Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
• Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, ≥6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion, no lymphovascular infiltration, free vertical resection margins and not poorly differentiated)
2. Prague Classification Score C≤3
3. Patients should be ablative-naïve, meaning they did not undergo any previous ablation therapy of the esophagus
4. Older than 18 years of age at time of consent
5. Operable per institution’s standards
6. Provides written informed consent on the IRB-approved informed consent form
7. Willing and able to comply with follow-up requirements
- Exclusion criteria1. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER >6 weeks prior to planned treatment under this protocol.
3. Prior ER >2cm in length and >50% of the esophageal lumen circumference
4. History of esophageal cancer
5. History of esophageal varices
6. Prior distal esophagectomy
7. Active esophagitis LA grade B or higher
8. Severe medical comorbidities precluding endoscopy
9. Uncontrolled coagulopathy
10. Pregnant or planning to become pregnant during period of study
11. Patient refuses or is unable to provide written informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate1-jan-2019
- Target number of participants18
- InterventionsPatients with a Barrett's Esophagus will be treated with the cryoballoon swipe system. This includes a first treatment covering 50% of circumference and over a length of 3 cm. Patients in phase II will subsequently be treated on the residual 50% of circumference at a second treatment with the swipe system.

The cryoballoon swipe system is an ablative device that freezes (ablates) the esophageal mucosa over a length of 3 cm.
- Primary outcome1) Safety will be evaluated by the incidence of Dose-related SAEs
2) Efficacy (eradication percentage as determined with the EGD-AC plus histological evidence of eradication of BE, after circumferential treatment with the therapeutic dose).
- Secondary outcome1. Incidence of all serious and non-serious adverse events up to 30 days post-treatment
2. Post-procedure pain in the area of the cryoablation treatment (scored on a 1 to 10- point VAS),
3. Efficacy, defined as the regression percentage at the first follow-up endoscopy, after 1 treatment covering 50% of circumference, with the therapeutic dose
4. Efficacy for treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with >80% regression of BE after 1 semicircumferential resp. fully circumferential treatment
- Timepoints2 months (+/- 2 weeks) post baseline treatment
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.N. van Munster
- CONTACT for SCIENTIFIC QUERIES S.N. van Munster
- Sponsor/Initiator C2 Therapeutics
- Funding
(Source(s) of Monetary or Material Support)
C2 Therapeutics
- Publications
- Brief summaryThe objective of this study is to evaluate the safety and efficacy of the CryoBalloon Swipe Ablation System for the ablation of dysplastic Barrett’s epithelium, in increasing doses.
- Main changes (audit trail)
- RECORD26-okt-2016 - 5-mrt-2017


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