Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus

NCT01572987

Barrett's Esophagus Esophageal Neoplasms

TERMINATED NA

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

NCT02953418

Esophageal Squamous Cell Neoplasia (ESCN)

TERMINATED NA

Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus

NCT05051475

Barrett Esophagus Esophageal Adenocarcinoma Reflux Disease

COMPLETED NA

Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma

NCT01961778

Barrett's Esophagus

COMPLETED NA

Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia

NCT02605759

Esophageal Squamous Cell Dysplasia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A patient population with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3 month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved. All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at 12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional treatment if necessary. Patients with no CR at 12 months are considered failures.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ESOPHAGEAL SQUAMOUS CELL CARCINOMA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiofrequency ablation

To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN

Group Type EXPERIMENTAL

Radiofrequency Ablation

Intervention Type DEVICE

Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiofrequency Ablation

Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RFA Barrx ablation system HALO ablation system

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject is 18-80 years of age, inclusive

1. Within the last 3 months, subject demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus, or...
2. within the last 3 months, subject demonstrated a new diagnosis of a flat-type (type 0-IIb) SCCA (G1/G2 only)
3. On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and has MGIN or worse (MGIN+) on biopsy
4. The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
5. Baseline EUS (all patients) shows no exclusionary findings for the trial
6. CT scan of chest and upper third of the abdomen (all HGIN and SCCA patients) shows no exclusionary findings for the trial
7. Subject is not pregnant nor 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)
8. Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
9. The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation

Exclusion Criteria

the Eligibility CRF.

1. Esophageal stricture preventing passage of a therapeutic endoscope
2. Any prior endoscopic resection
3. Any esophageal dilation in the past 12 months
4. Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage) prior to 3 months before screening for this trial
5. Any N or M positive status, if patient has a present diagnosis of esophageal SCCA
6. 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.
7. Any previous esophageal surgery, except fundoplication without complications (i.e. no slippage, dysphagia, etc)
8. Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
9. Evidence of eosinophilic esophagitis on endoscopy and/or histology
10. 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)
11. Subject is using aspirin, clopidogrel, or non-steroidal anti-inflammatory drugs that can not be discontinued 7 days before and after therapeutic sessions
12. Subject 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
13. Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
14. Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
15. Subject has life expectancy less than 2 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No