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

NCT ID: NCT02953418

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2019-07-20

Brief Summary

Multicenter, prospective cohort clinical trial in greater China

Conditions

Esophageal Squamous Cell Neoplasia (ESCN)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Radiofrequency ablation

Intervention Type: DEVICE

RFA

Interventions

Radiofrequency ablation

RFA

Intervention Type: DEVICE

Other Intervention Names

The Barrx™ Flex Radiofrequency Ablation System

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Cafaro, RN

Role: STUDY_DIRECTOR

Medtronic Gastrointestinal & Hepatology

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

COVB3050540

Identifier Type: -

Identifier Source: org_study_id