Clinical trial NCT03120195: EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
Official title: EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barretts Esophagus With Dysplasia
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
Collaborators: name: Interscope, Inc.
First posted: 2017-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis
timeFrame: 3 months
measure: Feasibility of EndoRotor® for the ablation of Barrett's mucosa
timeFrame: 3 months
Secondary outcomes:
measure: To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10)
timeFrame: 1 month
measure: To assess the dysphagia-score (recorded using the Ogilvie score)
timeFrame: 1 month
measure: To assess a variety of symptoms (recorded using a 7 point Likert scale)
timeFrame: 1 month
measure: Total time to resect tissue
timeFrame: Procedure
measure: Ease of performing the EndoRotor® procedure
timeFrame: Procedure
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC, University Medical Center
Study officials:
affiliation: Erasmus MC, University Medical Center Rotterdam
name: Arjun D. Koch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gotink AW, Peters Y, Bruno MJ, Siersema PD, Koch AD. Nonthermal resection device for ablation of Barrett's esophagus: a feasibility and safety study. Endoscopy. 2022 Jun;54(6):545-552. doi: 10.1055/a-1644-4326. Epub 2021 Dec 21.