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Semi-barbed Suture for Pulmonary Small Nodules Localization

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
absorbable semi-barbed suture
Sponsored by
Beijing Aerospace General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Suture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing aerospace general hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Semi-barbed Sutures Localization Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 17, 2019
Last Updated
June 20, 2021
Sponsor
Beijing Aerospace General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04168359
Brief Title
Semi-barbed Suture for Pulmonary Small Nodules Localization
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
March 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Aerospace General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suture, Nodule, Solitary Pulmonary, Video-Assisted Thoracoscopic Surgery

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semi-barbed Sutures Localization Group
Arm Type
Experimental
Arm Description
Patients with pulmonary nodules requiring CT-guided puncture positioning before thoracoscopic surgery
Intervention Type
Device
Intervention Name(s)
absorbable semi-barbed suture
Intervention Description
Positioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device
Primary Outcome Measure Information:
Title
Success rate
Description
Successfully located around the small nodules in the lungs, no dislocation occurred
Time Frame
half an hour after locating

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing aerospace general hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100076
Country
China

12. IPD Sharing Statement

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Semi-barbed Suture for Pulmonary Small Nodules Localization

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