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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02483052 |
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Date of registration:
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24/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RejuvenAir Lobectomy for Safety and Histology
LobectomyCAN |
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Scientific title:
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A Prospective Study of RejuvenAir System Radial Spray Cryotherapy to Determine Safety and Delayed Histological Effect in the Lung |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02483052 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Kashif Irshad, MDCM, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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WIlliam Osler Health Systems |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lung Neoplasms
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Pulmonary Neoplasms
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Intervention(s)
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Device: RejuvenAir
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Primary Outcome(s)
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Safety measured by occurrence of serious adverse events related to metered dose radial spray cryothreapy
[Time Frame: prior to lobectomy-up to 14 days]
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Secondary Outcome(s)
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Histology assessed by description of depth of histological treatment effect per specified treatment dose
[Time Frame: up to 90 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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