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OpenTrials
Completed

NCT Number: NCT04168359

Semi-barbed Suture for Pulmonary Small Nodules Localization

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.

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Key information

Conditions

Suture Lung Diseases Nodule, Solitary Pulmonary Respiratory Tract Diseases Solitary Pulmonary Nodule Video-Assisted Thoracoscopic Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing aerospace general hospital

Beijing, Beijing Municipality, 100076, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

absorbable semi-barbed suture

Device

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

Primary outcomes

  1. Success rate

    Time frame: half an hour after locating

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

Sponsors and collaborators

Lead sponsor

Beijing Aerospace General Hospital

Other

Registry information

Official study title

A Clinical Application Study of a CT Guided Small Pulmonary Nodule Puncture and Positioning Device Based on Pre-filled Absorbable Semi-barbed Wire

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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