A Clinical Application Study of a CT Guided Small Pulmonary Nodule Puncture and Positioning Device Based on Pre-filled Absorbable Semi-barbed Wire
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Suture
- Sponsor
- Beijing Aerospace General Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Success rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •solid nodules with a diameter2cm and distance to visceral pleura 0.5cm；
- •part-solid GGN, with a solid portion1cm and distance to the visceral pleura 1cm；
- •Patients with nodules at a deep location, who underwent localization to facilitate localization in the resected specimen by a pathologist
Exclusion Criteria
- •The lesion site is not suitable for percutaneous lung puncture;
- •those who have pneumothorax and pleural effusion;
- •Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;
- •Those who refuse surgery;
- •Those who did not sign the informed consent form.
Outcomes
Primary Outcomes
Success rate
Time Frame: half an hour after locating
Successfully located around the small nodules in the lungs, no dislocation occurred