Lung Cancer Clinical Trial
— MR&3D LocalOfficial title:
Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.
NCT number | NCT04552054 |
Other study ID # | 46783912 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | December 1, 2020 |
This study evaluates the viability and accuracy of preoperative mixed reality technique combined with three-dimensional printing navigational template guided localizing pulmonary small nodules.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | December 1, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - a maximum target lung nodule (one or more) diameter =20 mm - a target nodule CTR <0·25 or a minimum distance from the outer edge of the nodule to the nearest pleural surface >10 mm if the target nodule CTR was >0·25. - Plan to perform VATS lung wedge resection Exclusion Criteria: - Inability to comply with research protocols or research procedures - Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (= New York Heart Association [NYHA] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease - Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture - Pregnant or lactating women - Other circumstances that the investigator believes are not suitable for enrollment |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Provincial People's Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Wen-zhao ZHONG | Guangdong Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Puncture success rate of localization | The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization. | During surgery | |
Secondary | Time of localization | To evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively. | During surgery |
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