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Microwave Ablation
Microwave Ablation for Lung Cancer
N/A
Recruiting
Research Sponsored by Ethicon, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Oligometastatic lung tumor(s) planned to be ablated in the outer two-thirds of the lung and not closer than 1cm to the pleura.
Performance status 0-2 (Eastern Cooperative Oncology Group classification (ECOG))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month visit
Awards & highlights
Study Summary
This trial is testing a new way to destroy cancer cells in the lungs using microwaves, while using CT imaging to guide the placement of the probe tip. The primary endpoint is whether or not this new method is effective in destroying the cancer cells.
Who is the study for?
Adults (22+ years) with a few lung cancer spots, good performance status (able to carry out daily activities), and tumors in specific lung areas can join. They must not need continuous ventilator support, have severe lung damage, brain metastases, recent other lung treatments or be on certain blood thinners.Check my eligibility
What is being tested?
The study tests a new way to treat small areas of cancer in the lungs using microwave energy guided by advanced robotic technology and CT scans. The goal is to see how well it works one month after treatment.See study design
What are the potential side effects?
Possible side effects may include discomfort at the procedure site, bleeding, infection risk increase due to probe insertion into the lungs, and potential damage to nearby tissues or organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung tumor is in the outer part of the lung and not near the lung surface.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am 22 years old or older.
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My lung tumor is in the outer part of the lung and not near the lung surface.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-month visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Technique Efficacy
Secondary outcome measures
Change in EORTC QLQ-C30
Change in EORTC QLQ-LC13
Change in Pulmonary Function Tests (Diffusion Capacity)
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Transbronchial Microwave AblationExperimental Treatment1 Intervention
Transbronchial microwave ablation will be performed using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone.
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Who is running the clinical trial?
Ethicon, Inc.Lead Sponsor
91 Previous Clinical Trials
60,176 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung tumor is in the outer part of the lung and not near the lung surface.I haven't had any systemic therapy like chemotherapy in the last 14 days.I cannot stop taking my blood thinning medication for 5 days before and up to 3 days after a procedure.I can take care of myself and am up and about more than 50% of my waking hours.My primary lung cancer is under control, and I have one or more small, spread tumors.I haven't had lung surgery or treatment in the last 30 days and won't have any before a month after joining the study.You have a pacemaker or other electronic devices in your chest.My lung cancer is located in the large airways.I cannot stop taking warfarin for 3-5 days before and after an ablation procedure.My lung function is severely reduced, or my condition is considered too severe by my doctor.I cannot stop taking my blood thinners for 3 days before and up to 3 days after a procedure.I use a ventilator continuously for a severe lung condition, not just for sleep apnea.You have a blood clotting problem that can't be fixed.I have or might have cancer that has spread to my brain.I have had a lung removed.Your platelet count is less than 50,000 per cubic millimeter.I am 22 years old or older.The doctor thinks you may not live for more than 6 months.I have received radiation therapy to the area planned for ablation.My lung tumor is in the outer part of the lung and not near the lung surface.
Research Study Groups:
This trial has the following groups:- Group 1: Transbronchial Microwave Ablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lung Cancer Patient Testimony for trial: Trial Name: NCT05299606 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many places are currently administering this research project?
"Currently, 10 distinct medical centres are accepting patients into this trial. These locations include Farmington, Pinehurst and Cleveland in addition to other locales. To reduce travel obligations, it is advisable to apply at the closest clinic available."
Answered by AI
How many participants have been admitted to this research initiative?
"This clinical trial mandates the inclusion of 145 qualified patients, who may join from UCONN Health in Farmington, Connecticut or FirstHealth Moore Regional Hospital in Pinehurst, North carolina."
Answered by AI
Is the research team currently seeking volunteers for this trial?
"The study is currently recruiting participants, as attested to on clinicaltrials.gov; it was initially posted on October 24th 2022 and revised most recently on November 4th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
What site did they apply to?
MD Anderson
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Tired of doing chemo therapy that seems to have no end and so far no promising.
PatientReceived 2+ prior treatments
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