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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41876

Enrollment

Registered

2015-03-10

Start date

2015-11-16

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysplasia in esophageal squamous tissue dysplastic esophageal squamous epithelium

Interventions

Endoscopic cryoablation. The System has two main components: the delivery catheter with balloon probe and a disposable handle containing the cryogenic fluid. Deployed through the working channel of

cryoablation

cryotherapy

dysplastic squamous epithelium

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
-Efficacy (% surface regression of each individual USL*s upon cryoablation)	—

Secondary

Measure	Time frame
-Device performance -Pain 2 days after cryoablation treatment - Histopathological characteristics of the ablated zone - Adverse events	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)