Clinical trial to evaluate safety and dose response using the C2 CryoBalloonTM 180 Ablation system for the treatment of dysplastic Barrett*s esophagus - C2 CryoBalloon 180 Ablation System Dose Response Study

C2 Therapeutics, contactpersoon Marcia Wachna0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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

•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

发起方

C2 Therapeutics, contactpersoon Marcia Wachna