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

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ClinicalTrials.gov Identifier: NCT02953418
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
Multicenter, prospective cohort clinical trial in greater China

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Neoplasia (ESCN) Device: Radiofrequency ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Trial of Endoscopic Radiofrequency Ablation for High-grade and Low-grade Intraepithelial Squamous Neoplasia Using the Barrx™ Flex Radiofrequency Ablation System
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Radiofrequency ablation
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
RFA
Other Name: The Barrx™ Flex Radiofrequency Ablation System




Primary Outcome Measures :
  1. percentage of subjects with complete response (CR) [ Time Frame: 12 month ]
    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


Secondary Outcome Measures :
  1. Proportion of patients with a CR after primary RFA, defined as absence of MGIN or worse in any of the biopsies from the treatment area at the three months visit [ Time Frame: month ]
  2. Proportion of patients demonstrating neoplastic progression, defined as detection of a more severe histological grade compared to the baseline at any follow-up visit [ Time Frame: 12 month ]
  3. Proportion of patients demonstrating MGIN or worse outside the TA during treatment phase or follow-up [ Time Frame: 12 month ]
  4. Proportion of patients requiring endoscopic resection of visible abnormalities in the TA during treatment phase or follow-up. [ Time Frame: 12 month ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is 18-85 years of age
  2. 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
  3. 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
  4. All lesions in the esophagus are completely flat (Paris type 0-IIb), both on WLE and Lugol's chromoendoscopy
  5. The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
  6. Baseline endoscopic ultrasound (EUS) (if applicable) shows no exclusionary findings for the trial
  7. Computed Tomography )CT( scan of chest and upper third of the abdomen (if applicable) shows no exclusionary findings for the trial
  8. Based on the judgment of the study endoscopist, the patient is eligible for treatment, follow-up endoscopy, and biopsy as required by the protocol
  9. 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
  10. The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation

Exclusion Criteria:

  1. Patient has esophageal squamous cell carcinoma (ESCC)
  2. Any non-flat (Paris type 0-I, 0-IIa, 0-IIc, 0-III) abnormalities anywhere in the esophagus
  3. 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)
  4. Any USL with MGIN or worse on biopsy outside the treatment area
  5. Esophageal stricture preventing passage of a therapeutic endoscope
  6. Prior endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) which occurred < 3 months before enrollment
  7. Any esophageal dilation in the past 12 months
  8. Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage)
  9. 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
  10. Previous esophageal surgery, except fundoplication without complications (i.e., no slippage, dysphagia, etc.)
  11. Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
  12. Patient has active reflux esophagitis grade C or D
  13. Evidence of eosinophilic esophagitis on endoscopy and/or histology
  14. Inner diameter of the esophagus measuring <18 mm
  15. 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)
  16. Patient is using anti-thrombotic agents that cannot be discontinued 7 days before and after therapeutic sessions
  17. Patient has an implantable pacing device (examples: automated implantable cardioverter defibrillator, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
  18. Patient has life expectancy less than 5 years
  19. Patient suffers from psychiatric or other illness and/or has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post- treatment instructions, or follow-up guidelines
  20. Patient is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
  21. The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
  22. Patient is pregnant or has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test to be eligible)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953418


Contacts
Contact: Shirin Hasan 408.328.7338 shirin.r.hasan@medtronic.com

Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Guiqi Wang, MD       wangguiq@126.com   
Principal Investigator: Guiqi Wang, MD         
Sponsors and Collaborators
Medtronic - MITG

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02953418     History of Changes
Other Study ID Numbers: COVB3050540
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms