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Procedure
Image-Guided VATS vs. Standard VATS for Lung Cancer
N/A
Recruiting
Led By Raphael Bueno, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must be 18 years and older
Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will compare the outcomes of two types of surgery for small pulmonary nodules.
Who is the study for?
This trial is for adults with small lung nodules or opacities no larger than 20 mm, suitable for iVATS surgery, and whose lesions are in the outer half of the lung. Candidates must be evaluated at specific thoracic surgery clinics. Pregnant or breastfeeding individuals are excluded.Check my eligibility
What is being tested?
The study is examining two surgical methods for removing small pulmonary nodules: image-guided Video-Assisted Thoracic Surgery (iVATS) versus standard VATS. Each patient's outcomes will be assessed individually without direct comparison between the two groups.See study design
What are the potential side effects?
While not explicitly listed, side effects may include typical risks associated with surgeries such as pain, infection risk at incision sites, potential complications from anesthesia, and recovery time variations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a lung spot or shadow smaller than 2cm that can be measured.
Select...
My cancer is in the outer part of my lung.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operating Room Time
Secondary outcome measures
Hospital Length of Stay
Radiation Exposure
Time for induction to incision
+1 moreOther outcome measures
Quantitative Analysis of CT scans
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: iVATS resectionExperimental Treatment1 Intervention
Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.
Group II: Standard VATS resectionActive Control1 Intervention
Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,675 Total Patients Enrolled
Raphael Bueno, MDPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Faulkner Hospital, Brigham & Women's Hospital, Dana-Farber Cancer Institute, Milford Regional Medical Center
Harvard Medical Sch (Medical School)
Boston Medical Center (Residency)
4 Previous Clinical Trials
1,441 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lung spot or shadow smaller than 2cm that can be measured.My surgeon has approved me for iVATS surgery.I am 18 years old or older.My cancer is in the outer part of my lung.
Research Study Groups:
This trial has the following groups:- Group 1: Standard VATS resection
- Group 2: iVATS resection
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this investigation still open?
"Affirmative. Clinicaltrials.gov reveals that this research project, which was first advertised on September 11th 2018, is currently seeking participants. A total of 200 individuals must be recruited from one medical facility to meet the study's needs."
Answered by AI
How many individuals are partaking in this experiment?
"Affirmative. Clinicaltrials.gov's records signify that this investigation, first announced on September 11th 2018, is currently enrolling 200 individuals at a single medical facility."
Answered by AI
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