NCT03120195

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

April 4, 2017

Last Update Submit

January 28, 2020

Conditions

Barretts Esophagus With Dysplasia

Outcome Measures

Primary Outcomes (2)

  • Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis

    Participants will have follow-up visits after the procedure during which the occurence of adverse events will be assessed. Adverse events will be classified according to the severity and onset timing.

    3 months

  • Feasibility of EndoRotor® for the ablation of Barrett's mucosa

    The percentage of endoscopically visible surface regression of Barrett's epithelium after 3 months post EndoRotor® treatment

    3 months

Secondary Outcomes (5)

  • To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10)

    1 month

  • To assess the dysphagia-score (recorded using the Ogilvie score)

    1 month

  • To assess a variety of symptoms (recorded using a 7 point Likert scale)

    1 month

  • Total time to resect tissue

    Procedure

  • Ease of performing the EndoRotor® procedure

    Procedure

Study Arms (1)

EndoRotor® ablation

EXPERIMENTAL

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®.

Device: The EndoRotor®

Interventions

The EndoRotor®DEVICE

The EndoRotor® 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.

EndoRotor® ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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®.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University Medical Center

Nijmegen, Netherlands

Location

Erasmus MC, University Medical Center

Rotterdam, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34521118DERIVED

Study Officials

  • Arjun D. Koch, MD, PhD

    Erasmus MC, University Medical Center Rotterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 19, 2017

Study Start

January 27, 2017

Primary Completion

January 21, 2019

Study Completion

June 18, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)