Lung Neoplasms Clinical Trial
— LobectomyCANOfficial title:
A Prospective Study of RejuvenAir System Radial Spray Cryotherapy to Determine Safety and Delayed Histological Effect in the Lung
Verified date | May 2017 |
Source | CSA Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RejuvenAir System treatment will be performed during preoperative bronchoscopy 2 to 90 days prior to prescheduled lung resection in Subjects requiring lobectomy for removal of peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that will be removed, distal to the anticipated margin of resection. Treatment should be at least 1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and examined histologically following surgical resection. Subject participation will be from 1 to 90 days and enrollment is anticipated to take 3 months. Subject having a RejuvenAir procedure and not going on to a resection for any reason will be followed for a maximum of 90 days for safety and undergo bronchoscopic evaluation of the treated airways at 90 days (+/- 4 Days)) post treatment.
Status | Completed |
Enrollment | 6 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Males and females of 21 to 75 years of age. - Subject is able to read, understand, and sign a written Informed Consent to participate in the study. - Subject is scheduled within 90 days from date of study treatment for a lobectomy unrelated to this study (upper and lower lobes only). Preferred range is 2-14 days from study treatment. - Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 40% of predicted. - Subject is able to undergo bronchoscopy in the opinion of the investigator or per hospital guidelines. - Subject is able to adhere to and undergo a scheduled bronchoscope procedure prior to their clinically scheduled lobectomy surgical procedure. Exclusion Criteria: - • Subject is pregnant, nursing, or planning to get pregnant during study duration. - Subject is scheduled to have a pneumonectomy or has had a previous contralateral pneumonectomy. - 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 procedure. - Subject has an acute pulmonary infection or pneumonia within 6 weeks prior to study bronchoscopy. - Subject has had COPD exacerbation within 6 weeks prior to study bronchoscopy. - Subject has bronchiectasis in the area to be treated. - Subject has bullous emphysema. Characterized as large bullae >3 centimeters and confirmed on CT. - Subject has had a Lung transplant. - Subject has had lung reduction surgery, including implanted emphysema stent (s) implanted, coils or other devices for treatment. |
Country | Name | City | State |
---|---|---|---|
Canada | William Osler Health System | Brampton | Ontario |
Lead Sponsor | Collaborator |
---|---|
CSA Medical, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety measured by occurrence of serious adverse events related to metered dose radial spray cryothreapy | prior to lobectomy-up to 14 days | ||
Secondary | Histology assessed by description of depth of histological treatment effect per specified treatment dose | up to 90 days |
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