Semi-barbed Suture for Pulmonary Small Nodules Localization

Beijing Aerospace General Hospital

Status: Completed

Conditions: Suture; Video-Assisted Thoracoscopic Surgery; Nodule, Solitary Pulmonary

Treatments: Device: absorbable semi-barbed suture

Study type: Interventional

Funder types: Other

Identifiers

NCT04168359

JH.2017.0579

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Semi-barbed Sutures Localization Group

Experimental group

Description:

Patients with pulmonary nodules requiring CT-guided puncture positioning before thoracoscopic surgery

Treatment:

Device: absorbable semi-barbed suture