The study objective is to demonstrate the feasibility and safety (measured by the occurrence of serious adverse events) of the RejuvenAir System Radial Spray Cryotherapy in a population of subjects who are scheduled to undergo a planned lobectomy or…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety as measured by occurrence of serious adverse events related to metered
dose radial spray cryotherapy treatment performed prior to scheduled lobectomy
or pneumonectomy surgery
Secondary outcome
Description of tissue depth effect per specified dose using routine tissue
staining.
Background summary
Cryotherapy results in cell destruction while leaving the extracellular matrix
of the treated tissue intact. There is extensive human experience with
cryotherapy to date, including use in the airways. CSA is developing the
RejuvenAir* System, which is a modified delivery system based on its FDA
cleared truFreeze® System to address less localized surface areas of the
airways in order to treat chronic bronchitis. The purpose of this open label,
single arm study is to demonstrate the feasibility and safety of the RejuvenAir
System powered by truFreeze Technology, in Subjects who are scheduled to
undergo lobectomy, and to understand the histological characteristics and
healing outcomes in the airways in humans. This study is expected to lead to
a study in Subjects with chronic bronchitis.
Study objective
The study objective is to demonstrate the feasibility and safety (measured by
the occurrence of serious adverse events) of the RejuvenAir System Radial Spray
Cryotherapy in a population of subjects who are scheduled to undergo a planned
lobectomy or pneumonectomy. A secondary objective is the description of tissue
depth effect per specified dose using routine tissue staining.
Study design
Prospective, open label, single arm, multicenter study
Intervention
Surgical lobectomy or pneumonectomy will proceed as clinically planned. On the
day of scheduled surgery, Subject will undergo, prior to te surgery, the
bronchoscopy procedure. Directly after the bronchoscopy a chest-X-ray will be
performed for safety evaluation to confirm no presence of pneumothorax or
adverse event from the procedure.
Study burden and risks
Patients will be screened under regular medical care for surgery. Due to the
bronchoscopy the anesthesia time will be 10 minutes extended. The bronchoscopy
cares a small risk of pneumothorax. Participating patients have no personal
gain or benefit.
91 Hartwell Avenue 91
Lexington MA 02421
US
91 Hartwell Avenue 91
Lexington MA 02421
US
Listed location countries
Age
Inclusion criteria
Subject is scheduled within 60 days, for a total lobectomy or pneumonectomy procedure unrelated to this study (upper and lower lobes only).
Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 50% of predicted.
Exclusion criteria
Subject is pregnant, nursing, or planning to get pregnant during study duration.
Subject has had prior radiation therapy which involved the lungs.
Subject has received chemotherapy within the past 6 months, or is anticipated to be treated with chemotherapy between initial study treatment and lobectomy/pneumonectomy procedure.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02106143 |
| CCMO | NL48864.042.14 |