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Clinical trial to evaluate safety and dose response of the C2 CryoBalloon 180 Ablation System


- candidate number27836
- NTR NumberNTR6683
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2017
- Secondary IDsC2 Therapeutics CP-0019 
- Public TitleClinical trial to evaluate safety and dose response of the C2 CryoBalloon 180 Ablation System
- Scientific TitleClinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus
- ACRONYMC2 CryoBalloon 180 Ablation System - Dose response study
- hypothesis
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus, Barrett's dysplasia, Cryoablation, Cryotherapy
- Inclusion criteria1. Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
- Diagnosis of LGD or HGD in BE (confirmed by central pathology review), 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 or limited submucosal invasion (SM1), no lymphovascular infiltration, free vertical resection margins and not poorly differentiated)
2. Prague Classification Score C≤3 and ≥M1
3. Patients should be ablation-naïve (no 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 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 of more than 2cm in length or >50% of the esophageal lumen circumference
4. History of locally advanced (>SM1) 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
12. Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study
13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2020
- Target number of participants18
- InterventionsPatients with a Barrett's esophagus will be treated with the CryoBalloon 180 Ablation System. This includes a first treatment covering 50% of the esophageal circumference and over a length of 3 cm in phase I. After establishment of the effective dose in phase I, patients in phase II will be treated first on 50% of the circumference and subsequently after an 8 week interval on the residual 50% during a second treatment.

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 by the EGDAdjudication Committee 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 epigastric or chest pain from the cryoablation treatment (0-10 VAS score), described as the mean and median pain scores at 24 hours and seven (7) days post-procedure.
3. Efficacy, defined as the regression percentage at the first followup endoscopy (after one (1) treatment covering 50% of the esophageal circumference, with the therapeutic dose)
4. Efficacy of treatment with CryoBalloon 180 Ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 semi-circumferential and after fully circumferential treatment.
- TimepointsDuration of the study in phase I is 8 weeks (+/- 2 weeks); in phase II 18 weeks (+/-4 weeks).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Anouk Overwater
- CONTACT for SCIENTIFIC QUERIES Anouk Overwater
- 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 180 Ablation System for the ablation of dysplastic Barrett’s epithelium, in increasing doses.
- Main changes (audit trail)
- RECORD8-sep-2017 - 16-sep-2017


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