Video-Assisted Thoracoscopic Surgery Clinical Trial
Official title:
A Clinical Application Study of a CT Guided Small Pulmonary Nodule Puncture and Positioning Device Based on Pre-filled Absorbable Semi-barbed Wire
Verified date | June 2021 |
Source | Beijing Aerospace General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hookwire and microcoil are currently the most widely used localization instruments. Although their success rate is relatively high in preoperative localization attempts, they may lead to consequences that negatively affect patient outcomes, such as pain because of the metal's hardness, localization failure due to wire detachment, and the presence of permanent traces of metal and foreign bodies . To overcome these disadvantages, we designed an absorbable semi-barbed suture to localize small intrapulmonary nodules (patent number: ZL201821444387.X). The results of the previous animal experiments were satisfactory, and it is now necessary to recruit 10 patients for clinical trials.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2, 2021 |
Est. primary completion date | March 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. solid nodules with a diameter2cm and distance to visceral pleura 0.5cm; 2. GGN; 3. part-solid GGN, with a solid portion1cm and distance to the visceral pleura 1cm; 4. Patients with nodules at a deep location, who underwent localization to facilitate localization in the resected specimen by a pathologist Exclusion Criteria: 1. The lesion site is not suitable for percutaneous lung puncture; 2. those who have pneumothorax and pleural effusion; 3. Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery; 4. Those who refuse surgery; 5. Those who did not sign the informed consent form. |
Country | Name | City | State |
---|---|---|---|
China | Beijing aerospace general hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Aerospace General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate | Successfully located around the small nodules in the lungs, no dislocation occurred | half an hour after locating |
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