Semi-barbed Suture for Pulmonary Small Nodules Localization

NCT04168359 | Completed

• 1 other identifier: JH.2017.0579
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Success rate

  Successfully located around the small nodules in the lungs, no dislocation occurred

  half an hour after locating

Study Arms (1)

Semi-barbed Sutures Localization Group

EXPERIMENTAL

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

Device: absorbable semi-barbed suture

Interventions

absorbable semi-barbed suture DEVICE

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

Semi-barbed Sutures Localization Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• solid nodules with a diameter2cm and distance to visceral pleura 0.5cm；
• GGN；
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Aerospace General Hospital: lead

Study Sites (1)

Beijing aerospace general hospital

Beijing, Beijing Municipality, 100076, China

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 19, 2019
• Study Start: December 9, 2019
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

CN (1)