Semi-barbed Suture for Pulmonary Small Nodules Localization

Not Applicable

Completed

• Conditions: Nodule, Solitary Pulmonary; Suture; Video-Assisted Thoracoscopic Surgery
• Interventions: Device: absorbable semi-barbed suture

• Registration Number: NCT04168359
• Lead Sponsor: Beijing Aerospace General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-17
• Study First Posted: 2019-11-19
• Study Start: 2019-12-09
• Primary Completion: 2021-03-02
• Study Completion: 2021-03-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-20
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Semi-barbed Sutures Localization Group	absorbable semi-barbed suture	Patients with pulmonary nodules requiring CT-guided puncture positioning before thoracoscopic surgery

Primary Outcome Measures

Name	Time	Method
Success rate	half an hour after locating	Successfully located around the small nodules in the lungs, no dislocation occurred

Trial Locations

Locations (1)

Beijing aerospace general hospital; 🇨🇳 Beijing, Beijing, China