An interventional study of RheOx in Chronic Bronchitis and COPD, sponsored by Gala Therapeutics, Inc.. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Gala Therapeutics, Inc. · Not applicable, Interventional, and Treatment
Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.
RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to 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 anaesthesia. 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 to several tests and questionnaires during the study including respiratory function tests.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's planned enrollment of 100 is close to the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →Gala Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RheOx is a CE-marked 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.
Device: RheOx
RheOX is a CE-marked 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.
Safety: Incidence of SAEs
Incidence of serious adverse events associated with RheOx treatment through 24 months
Time frame: Through end of study (24 months post bilateral treatment)
Quality of Life: CAT
COPD Assessment Test (CAT) questionnaire
Time frame: Through end of study (24 months post bilateral treatment)
Quality of Life: SGRQ
St. George Respiratory Questionnaire
Time frame: Through end of study (24 months post-bilateral treatment)
Pulmonary Function: FEV1
Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.
Time frame: Through end of study (24 months post-bilateral treatment)
Pulmonary Function: FVC
Forced Vital Capacity
Time frame: Through end of study (24 months post-bilateral treatment)
COPD Exacerbations
COPD Exacerbations
Time frame: Through end of study (24 months post-bilateral treatment)
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for Dec 2024, 59 months after the start.
Of 24 interventional studies with no phase under Bronchitis, Chronic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 47. This study's planned 59 months is above that.
How these figures are worked out, and which studies are left out of them.
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Gala Therapeutics, Inc.