RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia

NCT02953418 | Terminated Results DMC FDA Device

• 1 other identifier: COVB3050540
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter, prospective cohort clinical trial in greater China

Conditions

Esophageal Squamous Cell Neoplasia (ESCN)

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Complete Response (CR)

  The primary endpoint is the percentage of subjects with "complete response (CR)", defined as complete eradication of squamous histological abnormalities (MGIN or worse) within the treatment area (TA) at 12 months after the initial treatment session

  12 month

Secondary Outcomes (3)

• Complete Response at Three Months

  3 Months

• Complete Response Within the Treatment Area

  3, 6 and 12 Month

• Disease Progression Outside the Treatment Area

  Initial, 3, 6, 9 and 12 month

Study Arms (1)

Radiofrequency ablation

EXPERIMENTAL

Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation DEVICE

RFA

Also known as: The Barrx™ Flex Radiofrequency Ablation System

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18-85 years of age
• Patient has evidence of ESCN, within the last 3 months, patient demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus
• On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and greater than ¼ of the esophageal circumference and has MGIN or HGIN on biopsy, confirmed by central pathologist
• All lesions in the esophagus are completely flat (Paris type 0-IIb), both on WLE and Lugol's chromoendoscopy
• The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
• Based on the judgment of the study endoscopist, the patient is eligible for treatment, follow-up endoscopy, and biopsy as required by the protocol
• EMR or ESD occurred \> 3 months before enrollment, patients may be eligible for the study if procedure was curative (negative margins and no risk of lymph node involvement) and the patient has no other findings concerning for cancer
• The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation

You may not qualify if:

• Patient has esophageal squamous cell carcinoma (ESCC)
• Any non-flat (Paris type 0-I, 0-IIa, 0-IIc, 0-III) abnormalities anywhere in the esophagus
• Any abnormalities under WLE, Lugol's chromoendoscopy or NBI that are suspicious for ESCC anywhere in the esophagus (e.g. 'pink sign' USL, defined as a color change after Lugol's staining: initially whitish yellow and pink 2-3 minutes later)
• Any USL with MGIN or worse on biopsy outside the treatment area
• Esophageal stricture preventing passage of a therapeutic endoscope
• Prior endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) which occurred \< 3 months before enrollment
• Any esophageal dilation in the past 12 months
• Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage)
• Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) or any radiation therapy to the esophagus
• Previous esophageal surgery, except fundoplication without complications (i.e., no slippage, dysphagia, etc.)
• Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
• Patient has active reflux esophagitis grade C or D
• Evidence of eosinophilic esophagitis on endoscopy and/or histology
• Inner diameter of the esophagus measuring \<18 mm
• Report of uncontrolled coagulopathy with international normalized ratio (INR) \> 2 or platelet count \<75,000 platelets per µL (note: a complete blood count is not required for all subjects in this study)

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

The study was terminated early, therefore there was a limited data set for analysis.

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Medtronic MITG-RGI

Tumordirectedtherapiesclinical@Medtronic.com

303-882-6759

Study Officials

• Amanda Cafaro, RN

  Medtronic Gastrointestinal & Hepatology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 2, 2016
• Study Start: April 20, 2017
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)