Status:
ENROLLING_BY_INVITATION
C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
Lead Sponsor:
Pentax Medical
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective is to determine the safety, performance and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in treatment naïve patients with low- ...
Detailed Description
The procedure will be performed on an outpatient basis, and the CryoBalloon 180 Ablation system will be used for all ablations following the instructions for use provided with the product. Patients w...
Eligibility Criteria
Inclusion
- 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 6 weeks after endoscopic resection
- Prague Classification Score C≤3 and ≥M1
- Patients should be ablation-naïve (no previous ablation therapy of the esophagus)
- Older than 18 years of age at time of consent
- Operable per institution's standards
- Patient provides written informed consent on the IRB-approved informed consent form
- Patient is willing and able to comply with follow-up requirements.
Exclusion
- Esophageal stenosis preventing advancement of a therapeutic endoscope
- 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.
- Prior ER of more than 2cm in length or \>50% of the esophageal lumen circumference
- History of locally advanced (\>SM1) esophageal cancer
- History of esophageal varices
- Prior distal esophagectomy
- Active esophagitis LA grade B or higher
- Severe medical comorbidities precluding endoscopy
- Uncontrolled coagulopathy
- Pregnant or planning to become pregnant during period of study
- Patient refuses or is unable to provide written informed consent
- Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study
- General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Key Trial Info
Start Date :
January 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03311451
Start Date
January 16 2023
End Date
December 1 2026
Last Update
January 13 2025
Active Locations (5)
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1
AMC Medical Research B.V.
Amsterdam, Netherlands
2
UMC Groningen
Groningen, Netherlands
3
St. Antonius Hospital
Nieuwegein, Netherlands
4
Erasmus Medical Center
Rotterdam, Netherlands