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Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study

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ClinicalTrials.gov Identifier: NCT04722432
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
A novel OTS detachable probe system carried outside and along the flexible bronchoscope has been developed. Using this novel system, the operator can deploy the probe in the target bronchus and lesion and completely detach the scope from the probe.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Outside the Scope (OTS), Detachable Catheter System Not Applicable

Detailed Description:
Lung ablative therapies have growing interest in the treatment of early-stage primary lung cancer in surgical high-risk patients and as part of multimodal treatment in patients with large lesions or metastatic malignant disease in the lungs. Endobronchial ablative strategies allow deliver y of these therapies through a natural orifice and minimally invasive approach, potentially improving safety and reducing related morbidity. Application and deployment of this system allows the operator to have constant control of the airway, preventing life-threatening hemoptysis and other complications. We hypothesize that this novel detachable OTS system can be successfully deployed in the peripheral parenchymal target with potential clinical applications in the near future.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : April 16, 2022
Estimated Study Completion Date : October 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Système de cathéter détachable dehors du scope (DDS) Device: Outside the Scope (OTS), Detachable Catheter System
Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study




Primary Outcome Measures :
  1. accuracy of the deployment method [ Time Frame: Time of procedure ]
    will be measured by bidimensional fluoroscopy images (antero-posterior and latero-lateral). The deployment will be considered successful if the tip of the probe is positioned at a distance less than 5 mm in both axes from the target model and stay stable in place over 5 minutes of ventilation.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who follow surgery for the removal of diseased lungs before being submitted to a bilateral lung transplant.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722432


Contacts
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Contact: Adeline Jouquan, MsC 514-890-8000 ext 26214 adeline.jouquan.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CHUM Recruiting
Montréal, Quebec, Canada
Contact: Adeline Jouquan, MSc    514-890-8000 ext 26214    adeline.jouquan.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04722432    
Other Study ID Numbers: CE 20.220
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No