EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study

Foundation for Liver Research

Status: Completed

Conditions: Barretts Esophagus With Dysplasia

Treatments: Device: The EndoRotor®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03120195

2016-688

Details and patient eligibility

About

The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.

Full description

Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. These include patients with low grade dysplasia (LGD), high grade dysplasia (HGD) or residual Barrett's after a complete endoscopic resection of a lesion containing HGD or esophageal adenocarcinoma. Ablation treatment will be performed by the EndoRotor ablation device, followed by surveillance endoscopy at 3 months where the feasibility for ablation will be assessed. During the 3 months follow-up, all adverse events such as perforation, post-procedural bleeding, stricture, and pain will be registered.

The EndoRotor® System is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent.

• Age equal to or above 18 years (adult).

• Minimum (residual) Barrett's length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)

• Scheduled Barrett's ablation for:

  • Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion,
  • Residual Barrett's mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR <50% of the circumference)

• Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.

Exclusion criteria

• Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
• In case of previous EMR: EMR specimen showing deep submucosal invasion (> 500μm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins.
• In case of previous EMR: > 50% circumference.
• Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
• Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
• Evidence of portal hypertension, esophageal varices, etc.
• An interval < 6 weeks between EMR and EndoRotor treatment.
• An interval of > 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia.
• Unable to undergo endoscopic procedure using sedation analgesics.
• Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

EndoRotor® ablation

Experimental group

Description:

Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. Barrett's ablation will be performed using the EndoRotor®.

Treatment:

Device: The EndoRotor®