Clinical trial to evaluate safety and dose response using the C2 CryoBalloonTM 180 Ablation system for the treatment of dysplastic Barrett*s esophagus

Completed

Conditions: 10017990
10017991
Barrett's esophagus
esophageal cancer

Registration Number: NL-OMON48956

Lead Sponsor: C2 Therapeutics, contactpersoon Marcia Wachna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

Patients must meet ALL of the following criteria to be eligible for
participation in the study:
1. Flat- type BE esophagus, with an indication for ablation therapy, defined as:
a. Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological
analysis), OR
b. Residual BE with any grade of dysplasia after endoscopic resection (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, meaning they have not undergone 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 Criteria

1. 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