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  5. Virtual Public Workshop –– Study Design Considerations for Transbronchoscopic Thermal Ablation Devices for the Treatment of Oligometastases to the Lung; April 5 & 6, 2022 - 04/05/2022
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Virtual

Event Title
Virtual Public Workshop –– Study Design Considerations for Transbronchoscopic Thermal Ablation Devices for the Treatment of Oligometastases to the Lung; April 5 & 6, 2022
April 5 - 6, 2022

Date:
April 5 - 6, 2022
Time:
11:00 AM - 5:00 PM ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled "Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) Devices for the Treatment of Oligometastases to the Lung (OML)." The purpose of the workshop is to provide a forum for stakeholders, including clinicians and professional societies, patients, and manufacturers to share information to develop appropriate regulatory review approaches to ensure the safety and effectiveness of this novel local therapy for the treatment of OML.

BACKGROUND

Earlier diagnosis and improved treatment of primary tumors across various anatomical sites has led to the increased need for clinical management strategies for patients presenting with OML. Current treatments include systemic drug therapy, surgical metastasectomy, stereotactic body radiation therapy (SBRT), or CT-guided percutaneous thermal ablation. Recently, the transbronchoscopic approach for catheter delivery of thermal ablation to lung oligometastases has been proposed as a less invasive treatment that may be associated with lower morbidity. However, there is currently a lack of consensus on the role of local therapy in the management of OML and how the safety and effectiveness of new local therapies such as TTA should be evaluated. This public workshop will cover definitions of disease, identification of appropriate patient populations for TTA, and key study design considerations including the most appropriate safety and effectiveness endpoints, control arms, duration of followup, and the role of surrogate endpoints (e.g. local control) in the evaluation of device effectiveness. The workshop will also include a session to obtain patient perspectives on the challenges they experience with OML and what is important to them when considering the benefits and risks of a novel local device therapy.

DATE

This workshop will be held on April 5, 2022, 11:00 am – 3:35 pm and April 6, 2022, 11:00 am - 5:00 pm (ET) by webcast only.

WEBCAST

The virtual public workshop will be a live webcast and the link will be provided in your confirmation email if you registered. The link for archived webcast will be posted to this webpage for viewing after the public workshop.

PRELIMINARY AGENDA

This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

Day 1: April 5, 2022

Time Title
11:00 AM  FDA Welcome
11:05 AM Medical Device Regulation
11:30 AM Professional Society Statements
12:30 PM LUNCH BREAK
1:00 PM Session 1 – Oligometastases to the Lung (OML) Overview
1:30 PM PANEL 1: Parameters defining OML
2:30 PM THE PATIENT PERSPECTIVE
3:30 PM FDA Closing Remarks for Day 1
3:35 PM Adjourn for Day 1

Day 2: April 6, 2022

Time Title
11:00 AM  FDA Opening Remarks
11:05 AM Session 2 – Suitability of local treatments of OML and its dependence on histology and other parameters
11:35 AM PANEL 2: Defining an appropriate patient population and goals of local treatment for TTA
12:35 PM LUNCH BREAK
1:00 PM Session 3: Overview of prior/ongoing study designs for evaluating the safety and effectiveness of local therapies for OML
1:45 PM PANEL 3: Clinical Trial Design for TTA Devices for OML
2:45 PM BREAK
3:00 PM Session 4: Appropriate Safety Profiles for TTA Overview of safety profiles for OML
3:30 PM PANEL 4: Safety Evaluations for TTA in the treatment of OML
4:30 PM Moderator Summaries from each Panel (5 min per Panel) and FDA Concluding Remarks
5:00 PM ADJOURN WORKSHOP

REGISTRATION

If you wish to attend this workshop, you must register by 4:00 p.m. on April 4, 2022. There is no fee to register for the workshop. Registration will be on a first-come, first-served basis. When registering, you must provide the following information:

No dashes or spaces in phone numbers please.
 

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, [email protected].

SUBMIT COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2021-N-1312 by May 6, 2022.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.

CONTACT

For questions regarding workshop content please contact:

Jeanne Oxley, MBA
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Email: [email protected]

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