Feasibility and efficacy of CryoBalloon Focal Ablation System on dysplastic esophageal squamous cell tissue: a proof of principle

Completed

Conditions: 10017990
dysplasia in esophageal squamous tissue
dysplastic esophageal squamous epithelium

Registration Number: NL-OMON41876

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

- Patients with at least one unstained lesion (USL) *1.5cm2 in the esophagus upon high resolution endoscopy (HRE) with Lugol*s staining
- Completely flat (type 0-IIb) lesions inside the USL or, in case of a prior type 0-IIa/IIc lesion, endoscopic resection of these lesions *8 weeks before cryoablation
- Proven medium-grade or high-grade intraepithelial neoplasia (MGIN or HGIN) in at least one USL
- In case of prior endoscopic resection: endoscopic resection specimens must have demonstrated *T1m3, negative deep resection margins, good or moderate tumor differentiation, no signs of lymphovascular invasion
- Age between 18 and 85
- Signed informed consent

Exclusion Criteria

- Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
- Patient with a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
- Patient refuses or is unable to provide written informed consent.
- Patients that are pregnant.
- Patient with endoscopically active inflammation in the treatment zone.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Efficacy (% surface regression of each individual USL*s upon cryoablation)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Device performance<br /><br>-Pain 2 days after cryoablation treatment<br /><br>- Histopathological characteristics of the ablated zone<br /><br>- Adverse events</p><br>