NCT03631472

Gala Early Feasibility Study of RheOx

A Feasibility Study: A Safety Evaluation of RheOx on Patients With Chronic Bronchitis in the United States

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Gala Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

RheOx is a device-based, energy delivery system that delivers energy for the ablation of soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies. Subjects will be required to submit tests during the study including three CT scans (lung), respiratory function tests, exercise testing.

Conditions

• Chronic Bronchitis
• Copd Bronchitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-06
• Primary completion: 2021-01-30
• Completion: 2024-12-30
• First posted: 2018-08-15
• Last updated: 2022-05-09
• Results posted: 2022-05-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study