Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 89
Healthy Volunteers: No
View:

• Subjects who are greater than 30 and less than 90 years of age; inclusive of males and females.

• Subjects with confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:

• Failed 3 ablative procedures (RFA and/or Cryotherapy).

• Failed at least 1 ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-procedure dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.

• Residual Barrett's length is ≥1 cm and ≤6 cm.

• No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy.

• Subject capable of giving informed consent.

• Subject has a reasonable expectation for prolonged survival (greater than 2 years).

• Subject can tolerate repeated endoscopic procedures.

• Absence of strictures refractory to dilation that preclude the passage of the endoscope

• Patients who were on acid suppression therapy (i.e. PPIs) during the course of failed primary ablative therapy, and who can continue acid suppression therapy for the entire time they are on the clinical study.

• Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 12 months, as indicated.

Locations
United States
Minnesota
The Mayo Clinic
Recruiting
Rochester
New York
University of Rochester Medical Center
Recruiting
Rochester
Other Locations
Sweden
Sahlgrenska University Hospital
Recruiting
Gothenburg
United Kingdom
NHS University College Hospital
Recruiting
London
Nottingham University Hospitals NHS Trust and University of Nottingham
Recruiting
Nottingham
Contact Information
Primary
Alexis James, BA
alexis.james@interscopemed.com
508-847478
Backup
Jeffery B Ryan Jr, BA
jeffery.ryan@interscopemed.com
617-360-1168
Time Frame
Start Date: February 9, 2018
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 120
Treatments
Experimental: EndoRotor Resection
For the purpose of this study the EndoRotor System is investigationally indicated for use during endoscopic procedures to resect and remove refractory Barrett's esophagus tissue in conjunction with a submucosal saline injection mix using adrenaline and dye. Subjects randomized to the EndoRotor arm will be treated up to 3 times through the 9 month follow-up period to remove gross visible Barrett's.
Active Comparator: Continued Ablation (Control)
The investigator shall exercise standard of care for subjects undergoing continued ablative therapies (RFA and/or Cryotherapy). These will constitute the control devices. The investigator will choose the system in this arm. Operation of each system will be done according to the manufacturer's IFU. Subjects randomized to the control arm may be treated up to 3 time through the 9 month follow-up period to remove gross visible Barrett's.
Authors
Rehan HaI, Gary Falk, Kenneth Wang, Charles Lightdale, Gregory Ginsberg, Vivek Kaul, Rehan Haidry, Jacobo Ortiz, Nima Mottacki
Related Therapeutic Areas
Sponsors
Leads: Interscope, Inc.

This content was sourced from clinicaltrials.gov

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