Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-02-16

Brief Summary

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

Barrett's esophagus is a condition in which the normal lining of the lower esophagus is replaced with cells that predispose an individual to development of esophageal cancer. Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is provided endoscopically, via a variety of approved techniques including endoscopic mucosal resection, argon plasma coagulation, radiofrequency ablation (RFA), spray cryotherapy ablation and balloon cryotherapy ablation. A common side effect of ablation treatment is pain, thus making pain an important factor when discussing treatment options. It is speculated that balloon cryotherapy causes less pain than RFA but no head-to-head comparison trials exist to date. This multi-center, prospective cohort study aims to compare pre- and post-procedural pain for balloon cryotherapy versus RFA. Providing both patients and clinicians with data from a well-designed prospective study may help guide future physician/patient treatment discussions.

Related Clinical Trials

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

Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer

NCT00321958

Barrett Esophagus Esophageal Neoplasms Deglutition Disorders +2 more

TERMINATED

Endoesophageal Cryotherapy For Ablating Barrett's Esophagus and Early Stage Esophageal Cancer

NCT00628784

Barrett's Esophagus

UNKNOWN PHASE4

Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique

NCT03621319

Barrett's Esophagus High-grade Dysplasia in Barrett Esophagus Low Grade Dysplasia in Barrett Esophagus

TERMINATED NA

Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

NCT00526786

Barrett's Esophagus High Grade Dysplasia Low Grade Dysplasia

TERMINATED PHASE4

Argon Plasma Coagulation for Barrett's Esophagus

NCT04154748

Barretts Esophagus With Low Grade Dysplasia

COMPLETED NA

Detailed Description

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

Conditions

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

Barrett Esophagus

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Balloon Cryotherapy Treatment Group

Subjects will undergo endoscopic balloon cryotherapy for dysplastic Barrett's Esophagus as per standard of care. The treatment type (balloon cryotherapy vs RFA) is determined by the endoscopy physician at the time of the procedure and is based on several clinical factors including co-existing medical conditions, the anatomy of the esophagus, and the length and amount of tissue affected with Barrett's.

No interventions assigned to this group

RFA Treatment Group

Subjects will undergo radio frequency ablation treatment for dysplastic Barrett's Esophagus as per standard of care. The treatment type (balloon cryotherapy vs RFA) is determined by the endoscopy physician at the time of the procedure and is based on several clinical factors including co-existing medical conditions, the anatomy of the esophagus, and the length and amount of tissue affected with Barrett's.

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

1. Patients with dysplastic Barrett's esophagus (LGD and HGD) naïve to ablation therapy presenting for ablation
2. Age ≥ 18
3. Ability to sign informed consent