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Trial Title:
Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial
NCT ID:
NCT05715996
Condition:
Lung Cancer
Conditions: Keywords:
mixed reality
Localization
sublobectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
mixed reality guided localization
Description:
In this study, MR was utilized to assist in the localization of pulmonary nodule during
sublobectomy lung resection in patient to assess the accuracy of the technique.
Arm group label:
mixed reality guided localization group
Summary:
With the popularization of CT screening, the detection rate of small lung nodules has
greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and
sub-lobectomy for radical resection of lung cancer are greatly required. Accurate
resection of lung nodule depends on precise localization of pulmonary nodules. However,
preoperative CT-guided Hook- wire positioning under local anesthesia, which is the
current primary localization method, requires high equipment and expense, and may cause
physical and mental trauma to the patient. Augmented reality (AR) is an innovative
technology that superimpose a virtual scene into the real environment by fusing images,
videos, or computer-generated models with patients during surgical operations. It can
visually display the anatomical structures of organs or lesions, which significantly
improves surgical efficiency. This project intends to use AR technology to localize the
solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire
localization. Compared with the localization of SPNs under CT guidance, AR-assisted
localization technology apparently is less time-consuming and can be performed
immediately before surgery under general anesthesia, lessening pain, reduce costs of time
and equipment, increase the success rate of sub-lobectomy, and improve the overall
efficiency of surgical treatment of pulmonary nodules.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female ≥ 18years of age;
2. There was no distant metastasis in preoperative clinical evaluation;
3. The attending physician evaluated and confirmed the need for lung nodule
localization and sub-lobectomy;
4. Target lung nodule diameter ≤ 2cm
5. The inner edge of the target node is at least 2 cm from the pulmonary artery or
pulmonary vein
6. preoperative ECOG physical state score 0/1;
7. Volunteer to participate in the study and sign the informed consent form.
Exclusion Criteria:
1. More than two lung nodules need to be removed at the same time.
2. The target node is located in the scapular region. Because percutaneous localization
is obstructed by the scapula, percutaneous localization of pulmonary nodules is not
suitable for such patients.
3. The patient has uncontrollable mental illness and cannot make subjective assessment.
4. After being selected, severe complications (unable to tolerate surgery or
anesthesia) occurred before operation are not suitable or the treatment plan of the
study cannot be implemented as planned;
5. After being selected, the patient's condition changes and needs to be changed from
elective surgery to emergency surgery after being confirmed by the competent doctor;
6. At any stage after entering the study, the patient voluntarily requests to withdraw
or discontinue treatment due to personal reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zuodong Song
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Zuodong Song
Email:
szd1990@hotmail.com
Start date:
May 23, 2023
Completion date:
March 2024
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05715996
