- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529603
The Efficacy of Intraoperative Pulmonary Nodules Localization Guided by Virtual Reality Technology
Study on the Localizing of Intraoperative Pulmonary Nodules Guided by Virtual Reality Technology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Ruijin Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon. • commit to follow the research procedures and cooperate with the implementation of the whole process research • 1 / 3 of pulmonary nodules are located in the periphery of the lung • signed informed consent with date
Exclusion Criteria:
• the target lesion is close to the hilar or large blood vessels • subjects with FEV1 less than 1.2 in lung function • subjects with cardiac function III and cardiac function IV (NYHA, New York) • subjects with uncontrollable acute pleura infection • patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side • Other factors that investigators disagree enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1
LungBrella marker implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery
|
The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software.
The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positioning success rate
Time Frame: Immediately after resection
|
When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful.
The success rate is the proportion of successful cases to all operation cases
|
Immediately after resection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure time
Time Frame: Duration of procedure
|
Collect total procedure time for lung localization and surgical resection.
|
Duration of procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hecheng Li, Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTS-012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Neoplasm
-
National Cancer Institute (NCI)RecruitingLocally Advanced Lung Neuroendocrine Neoplasm | Lung Neuroendocrine Neoplasm | Metastatic Lung Neuroendocrine Neoplasm | Recurrent Lung Neuroendocrine Neoplasm | Unresectable Lung Neuroendocrine Neoplasm | Advanced Lung Neuroendocrine Tumor | Functioning Lung Neuroendocrine Tumor | Lung Neuroendocrine... and other conditionsUnited States
-
Dartmouth-Hitchcock Medical CenterCompletedPrimary Malignant Neoplasm of Lung | Primary Malignant Neoplasm of Gastrointestinal TractUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung Carcinoma | Lung Neoplasm | Malignant Lung NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Metastatic Malignant Neoplasm in the LungUnited States
-
Mirati Therapeutics Inc.RecruitingMetastatic Cancer | Advanced Cancer | Malignant Neoplasm of LungKorea, Republic of, United States, Turkey, France, Taiwan
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Jiangsu ShengDiYa Medicine Co., Ltd.Dongguan People's HospitalUnknownNonsquamous Nonsmall Cell Neoplasm of Lung
-
Spanish Lung Cancer GroupCompletedNonsquamous Nonsmall Cell Neoplasm of LungSpain
-
SanofiTerminatedBreast Cancer | Gastric Cancer | Neoplasm | Lung Neoplasm Malignant | Neoplasm MalignantBelgium, Korea, Republic of, United States, Taiwan, Spain, France
-
Bavarian Cancer RegistryBavarian Association of Statutory Health Insurance Accredited PhysiciansNot yet recruitingNeuroendocrine Neoplasm of Lung | Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)
Clinical Trials on LungBrella marker implantation and VATS partial lobe resection
-
Ruijin HospitalShanghai Futuo Zhida Medical Technology Co., LtdCompleted