Clinical trial NCT02953418: RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Squamous Cell Neoplasia (ESCN)
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Percentage of Subjects With Complete Response (CR)
timeFrame: 12 month
Secondary outcomes:
measure: Complete Response at Three Months
timeFrame: 3 Months
measure: Complete Response Within the Treatment Area
timeFrame: 3, 6 and 12 Month
measure: Disease Progression Outside the Treatment Area
timeFrame: Initial, 3, 6, 9 and 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Medtronic Gastrointestinal & Hepatology
name: Amanda Cafaro, RN
role: STUDY_DIRECTOR
References: