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Gala Early Feasibility Study of RheOx

NCT03631472 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-05-09

Study results available
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Summary

An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States.

Conditions

  • Chronic Bronchitis
  • Copd Bronchitis

Interventions

DEVICE

RheOx

RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Sponsors & Collaborators

  • Gala Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2021-01-30
Completion
2024-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631472 on ClinicalTrials.gov