Semi-barbed Suture for Pulmonary Small Nodules Localization

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168359
• Other study ID #: JH.2017.0579
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: March 2, 2021

Study information

• Verified date: June 2021
• Source: Beijing Aerospace General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Nodule, Solitary Pulmonary
• Solitary Pulmonary Nodule
• Suture
• Video-Assisted Thoracoscopic Surgery

Intervention

Device:
• absorbable semi-barbed suture
Positioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device

Locations

Country	Name	City	State
China	Beijing aerospace general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Aerospace General Hospital

Country where clinical trial is conducted

China, 

Outcome

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