Esophageal Squamous Cell Neoplasia (ESCN)REACHNCT02953418

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

A study testing Radiofrequency ablation in people with Esophageal Squamous Cell Neoplasia (ESCN), run by Medtronic - MITG at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Multicenter, prospective cohort clinical trial in greater China Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Esophageal Squamous Cell Neoplasia (ESCN)
What is being tested?: Radiofrequency ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteChina
Study dates: 20 Apr 2017to 20 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
Baseline endoscopic ultrasound (EUS) (if applicable) shows no exclusionary findings for the trial

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Computed Tomography )CT( scan of chest and upper third of the abdomen (if applicable) shows no exclusionary findings for the trial
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

Who cannot join

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

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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)
Patient is using anti-thrombotic agents that cannot be discontinued 7 days before and after therapeutic sessions
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
Patient has life expectancy less than 5 years
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
Patient is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
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)

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021

Other trials in China

About this study

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

Multicenter, prospective cohort clinical trial in greater China

Conditions: Esophageal Squamous Cell Neoplasia (ESCN)
Being tested: Radiofrequency ablation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiofrequency ablationDevice
Also called The Barrx™ Flex Radiofrequency Ablation System
RFA

Study groups in NCT02953418
Study group	Role	What they receive
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. Receives: Device: Radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 month

Secondary outcomes (3)

Complete Response at Three Months
Number 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
Measured: 3 Months
Complete Response Within the Treatment Area
Number of patients demonstrating complete response within the treatment area (TA), defined as detection of ESCC in biopsy or resection specimen at any time within the first 12 months.
Measured: 3, 6 and 12 Month
Disease Progression Outside the Treatment Area
Proportion of patients demonstrating MGIN or worse outside the TA during treatment phase or follow-up
Measured: Initial, 3, 6, 9 and 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201720 Jul 2019

First posted2 Nov 2016 (estimated)
Study start20 Apr 2017
Primary completion20 Jul 2019
Study completion20 Jul 2019

Why it stopped: Enrollment taking longer than expected.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Esophageal Squamous Cell Neoplasia (ESCN)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02953418
Sponsor's protocol ID: COVB3050540
Acronym: REACH
Status last verified: Oct 2019
First submitted: 28 Oct 2016
Last updated: 12 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02953418
Acronym / sponsor ID: REACH / COVB3050540
Conditions: Esophageal Squamous Cell Neoplasia (ESCN)
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment taking longer than expected.
Enrolment: 34 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 20 Apr 2017 (actual)
Primary completion: 20 Jul 2019 (actual)
Study completion: 20 Jul 2019 (actual)
First posted: 2 Nov 2016 (estimated)
Results: Posted 12 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Multicenter, prospective cohort clinical trial in greater China

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Radiofrequency ablation	Experimental	Device: Radiofrequency ablationStep-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (22 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiofrequency ablationAlso: The Barrx™ Flex Radiofrequency Ablation SystemRFA	Device	Radiofrequency ablation

Primary outcome

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

3 secondary outcomes

Complete Response at Three Months
Time frame: 3 Months
Complete Response Within the Treatment Area
Time frame: 3, 6 and 12 Month
Disease Progression Outside the Treatment Area
Time frame: Initial, 3, 6, 9 and 12 month

Results and safety

Results posted to the registry on 12 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiofrequency Ablation	34	34

Primary outcome: Percentage of Subjects With Complete Response (CR)

Time frame: 12 month. Count of participants. Unit: Participants

Measure	Radiofrequency Ablation n = 8
Value	8

Population analysed: As the study was terminated early, only 8 subjects completed 12 month follow up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety data was evaluated throughout the entirety of follow up, after the study was terminated safety was evaluated for 90 days post RFA procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Radiofrequency Ablation	3 of 34 (8.8%)	1 of 34 (2.9%)	0 of 34

Limitations and caveats (from the sponsor): The study was terminated early, therefore there was a limited data set for analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amanda Cafaro, RN study director

Medtronic Gastrointestinal & Hepatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation in people with Esophageal Squamous Cell Neoplasia (ESCN), run by Medtronic - MITG at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Complete Response (CR) (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953418.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.