RejuvenAir Lobectomy for Safety and Histology (LobectomyCAN)
10 maj 2017 uppdaterad av: CSA Medical, Inc.
A Prospective Study of RejuvenAir System Radial Spray Cryotherapy to Determine Safety and Delayed Histological Effect in the Lung
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The study is a prospective, open label, single arm, single center study.
The objective is to study the safety of the RejuvenAir System in a population of subjects who are scheduled to undergo a planned lobectomy.
A secondary objective is to determine the histological effects of RejuvenAir System treatment in the airways.
The Primary Endpoint is Safety as measured by occurrence of serious adverse events related to metered dose radial spray cryotherapy treatment performed prior to scheduled lobectomy surgery.
The patient population intended to participate in this study are subjects scheduled to undergo lobectomy for peripheral lung lesions suspicious for or known to be cancer.
Secondarily, this will enable an understanding of the histological characteristics and healing outcomes post-treatment in the airways, which will be resected.
CSA Medical has conducted bench and animal studies that support the use of the RejuvenAir System as sufficiently safe and effective to warrant advancing the product into this primary safety study in patients presenting for consideration of lobectomy.
Such patients provide a safe population to further the clinical evaluation of the system in that these subjects will receive their lobectomy or procedure 2 to 14 days following delivery of their metered liquid nitrogen treatment.
At the time of their metered liquid nitrogen treatment they will be in an operating room setting with their thoracic surgeon in attendance.
It is anticipated that subjects who agree to participate in this study will have the metered liquid nitrogen treatment at the time of evaluation of their lung lesion.
This evaluation will include bronchoscopy with ultrasound for evaluation of their lymph nodes prior to the planned surgical resection of their lung abnormality.
Studietyp
Interventionell
Inskrivning (Faktisk)
6
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ontario
-
Brampton, Ontario, Kanada, L6R 3J7
- William Osler Health System
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: RejuvenAir
RejuvenAir if the treatment areas are designated as Segmental, males will be dosed for 11 seconds and females for 10 seconds.
If dosing is in the Lobar area males will be dosed for 12 seconds and females for 11 seconds.
|
RejuvenAir
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Safety measured by occurrence of serious adverse events related to metered dose radial spray cryothreapy
Tidsram: prior to lobectomy-up to 14 days
|
prior to lobectomy-up to 14 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Histology assessed by description of depth of histological treatment effect per specified treatment dose
Tidsram: up to 90 days
|
up to 90 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kashif Irshad, MDCM, MSc, WIlliam Osler Health Systems
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2015
Primärt slutförande (Faktisk)
1 februari 2016
Avslutad studie (Faktisk)
1 februari 2016
Studieregistreringsdatum
Först inskickad
24 juni 2015
Först inskickad som uppfyllde QC-kriterierna
25 juni 2015
Första postat (Uppskatta)
26 juni 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 013 (Nahrain Medical Research Collective (NMRC))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .