SutureNCT04168359
Semi-barbed Suture for Pulmonary Small Nodules Localization
A study testing absorbable semi-barbed suture in people with Suture and Nodule, Solitary Pulmonary, run by Beijing Aerospace General Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Suture, Nodule, Solitary Pulmonary, Video-Assisted Thoracoscopic Surgery
- What is being tested?
- absorbable semi-barbed suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2019to 2 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing aerospace general hospital
Beijing, Beijing Municipality, 100076
About this study
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
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.
- Being tested
- absorbable semi-barbed suture
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
absorbable semi-barbed sutureDevice
Positioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device
| Study group | Role | What they receive |
|---|---|---|
| Semi-barbed Sutures Localization Group | Experimental | Patients with pulmonary nodules requiring CT-guided puncture positioning before thoracoscopic surgery Receives: Device: absorbable semi-barbed suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Successfully located around the small nodules in the lungs, no dislocation occurred
Measured: half an hour after locating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start9 Dec 2019
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SutureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Aerospace General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168359
- Sponsor's protocol ID
- JH.2017.0579
- Status last verified
- Jun 2021
- First submitted
- 17 Nov 2019
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04168359
- Acronym / sponsor ID
- JH.2017.0579
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beijing Aerospace General HospitalUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-barbed Sutures Localization Group | Experimental | Device: absorbable semi-barbed suturePatients with pulmonary nodules requiring CT-guided puncture positioning before thoracoscopic surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| absorbable semi-barbed suturePositioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device | Device | Semi-barbed Sutures Localization Group |
Primary outcome
Success rate
Time frame: half an hour after locating
Successfully located around the small nodules in the lungs, no dislocation occurred
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing absorbable semi-barbed suture in people with Suture and Nodule, Solitary Pulmonary, run by Beijing Aerospace General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: half an hour after locating). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.