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

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04722432
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 16, 2020
• Anticipated Primary Completion Date: Apr 16, 2023
• Anticipated Study Completion Date: Oct 16, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. accuracy of the deployment method [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUM	Montréal	Quebec	Canada

Sponsors and Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT04722432
• Other Study ID Numbers: CE 20.220
• First Posted: Jan 25, 2021
• Last Update Posted: Jul 6, 2022
• Last Verified: Feb 1, 2022

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

Study Results

No Results Posted as of Jul 6, 2022