Semi-barbed Suture for Pulmonary Small Nodules Localization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2021-03-02

Brief Summary

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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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Detailed Description

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Conditions

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Suture Nodule, Solitary Pulmonary Video-Assisted Thoracoscopic Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Semi-barbed Sutures Localization Group

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

Group Type EXPERIMENTAL

absorbable semi-barbed suture

Intervention Type DEVICE

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

Interventions

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absorbable semi-barbed suture

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No