the Success Rate of Non Dilation on the Central Venous CatheterizationNDCVC-01NCT06652191
Non Dilation on the Central Venous Catheterization（NDCVC-01）
A study testing Direct catheterization with non-dilation and Catheterization after expanding the skin with a dilator in people with the Success Rate of Non Dilation on the Central Venous Catheterization, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The central venous catheter is widely used and used in high dosage, and various complications such as hematoma, hemopneumothorax and arterial puncture may occur during puncture and use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Success Rate of Non Dilation on the Central Venous Catheterization
- What is being tested?
- Direct catheterization with non-dilation and Catheterization after expanding the skin with a dilator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2024to 31 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) patients aged 18 years or older
- (2) patients with internal jugular vein catheterization
Who cannot join
- （1）Patients with infection at the puncture site
- （2）Patients with contraindications to central venous catheterization
- （3）Patients with imaging examination suggesting thrombosis in the internal jugular vein before puncture
- （4）Patients who refused to participate, did not sign or refused to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site
the Sixth Affiliated Hostipal, Sun Yet Sen University
Guangzhou, Guangdong, 510655
Sanqing Jin, MD, 0086-13719366863, sanqingjin@hotmail.com
Yingyin Zhao, 0086-13678943039, zhaoyy78@mail.sysu.edu.cn
About this study
Official title: Effect of Central Venous Puncture Dilation and Non Dilation on the Success Rate of Catheterization
The central venous catheter is widely used and used in high dosage, and various complications such as hematoma, hemopneumothorax and arterial puncture may occur during puncture and use. In addition to conventional techniques, studies have been done to improve the success rate of puncture and reduce the incidence of complications by modifying different procedures. However, among the complications caused by the procedure of percutaneous catheter placement, the fatal bleeding caused by skin dilation may threaten the patient' s life. There are few studies on dilators and skin dilation steps at home and abroad. In this study, the conventional puncture technique was improved and the skin dilation step was omitted, hoping to reduce complications, reduce puncture time, improve efficiency and improve patient comfort on the premise of ensuring the success rate of catheterization.
Read the detailed description
The Central venous catheter is widely used, but there are various complications. During the procedure of skin expansion with central venous catheterization, the use of a dilator can lead to complications such as hematoma, fatal bleeding, discomfort or serious threat to the patient's life. The aim of this study was to eliminate the procedure of skin expansion, to ensure the success rate of catheterization, to reduce complications, to reduce operation time, to improve efficiency, and to improve patients' comfort.
This study is a single-center, prospective, randomized controlled trial.The sample size was calculated by non-inferiority test:(1)the success rate of central venous catheterization was 97.98% according to Meta-analysis references;(2)α =0.025;(3)power 90%;(4)missed follow-up rate 20%, and ultimately 336 samples were included in the study,168 patients in each group.
Patients will receive written and verbal information about the trial before written consent is obtained. Randomization will take place on the day of surgery, and patients will be assigned to the intervention group (direct catheterization with non-dilation) or the control group (catheterization after expanding the skin with a dilator) . The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a research assistant.
Under ultrasound guidance, The patient will undergo central venous catheterization by an experienced anesthesiologist based on grouping information.In the control group, catheter was inserted after skin expansion with dilator, while in the test group, catheter was inserted directly with non-dilator.The success rate of catheterization, the total time of catheterization, and complications were recorded.The patients were followed up for 24 hours after surgery and asked about their comfort level.
Shapiro-Wilk test is used to test normality for continuous variables, with data expressed as mean ± standard deviation, and independent t-test is used for statistical analysis.For categorical data, the incidence of immediate complications is expressed as a percentage (%), and chi square test is used to statistically analyze the incidence of various complications.For the Primary outcome ,success rate of catheterization, the method of confidence interval is used. If the lower limit of confidence interval > negative non-inferiority threshold, the non-inferiority is considered. P < 0.05 was considered statistically significant.
- Being tested
- Direct catheterization with non-dilation, Catheterization after expanding the skin with a dilator
- Keywords
- non-dilation, central venous catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct catheterization with non-dilationProcedure or surgery
Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, place the catheter into the vessel directly along the guide wire without using an dilator to expand the skin
Catheterization after expanding the skin with a dilatorProcedure or surgery
Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, after the skin is expanded with a dilator, the catheter is inserted into the vessel along the guide wire
| Study group | Role | What they receive |
|---|---|---|
| The test group:Direct catheterization with non-dilation | Experimental | Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, place the catheter into the vessel directly along the guide wire without using an dilator to expand the skin Receives: Procedure: Direct catheterization with non-dilation |
| The control group: Catheterization after expanding the skin with a dilator | Active comparator | Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, after the skin is expanded with a dilator, the catheter is inserted into the vessel along the guide wire Receives: Procedure: Catheterization after expanding the skin with a dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Catheterization
The ratio of the number of successful catheterization to the number of participants in each group.
Confirm that the catheter in the target vessel is defined as:(1)The syringe smoothly draws back blood;(2)After the fluid is connected, the infusion drops flow smoothly
Measured: Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)
Secondary outcomes (3)
Total time of catheterization
This total time was defined as the time from the tip of the needle touching the skin to confirmation that the catheter was in the target vessel
Measured: Intraoperative (Start with the tip of the needle touching the skin until the catheter is in the target) vessel
Incidence of immediate complications
immediate complications include：arterial puncture; pneumothorax; hemothorax; hematoma; Oozing blood; arrhythmia.
definition: Arterial puncture : puncture of an artery with a needle during catheter placement.
Pneumothorax :a collection of air or gas in the pleural cavity, which can cause the lung to collapse, confirmed by positive imaging.
Hemothorax: a collection of blood in the pleural cavity, which can cause the lung to collapse, confirmed by positive imaging.
hematoma: hematoma on the ultrasonography surrounding the vessel, severe hematoma defined as a visible hemotama large enough to be seen outside the skin.
Oozing blood: Blood oozes from the skin at the point of puncture, or requiring dressing change.
arrhythmia:a irregular heartbeat, include premature beats; atrial tachycardia; paroxysmal supraventricular tachycardia; atrial flutter; atrial fibrillation and so on.
Measured: Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)
Patient Comfort Score
Patients were assessed for comfort using the visual analogue scale(0-10). 0 was very uncomfortable, 10 was very comfortable, and the higher the score, the more comfortable the patient was.
Measured: 24 hours after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start28 Oct 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for the Success Rate of Non Dilation on the Central Venous CatheterizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanqing Jin, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652191
- Sponsor's protocol ID
- 2024ZSLYEC-387
- Acronym
- NDCVC-01
- Status last verified
- Jul 2024
- First submitted
- 21 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
iData Research. Central Venous Catheter Market Size, Share & Trends Analysis, Global, 2020-2026. 2020. Accessed October 26, 2023
秦志均,等.改良中心静脉穿刺术对穿刺置管并发症的影响.现代临床医学2016( 04) :023
Collier PE. Prevention and treatment of dilator injuries during central venous catheter placement. J Vasc Surg Venous Lymphat Disord. 2019 Nov;7(6):789-792. doi: 10.1016/j.jvsv.2019.06.020. Epub 2019 Aug 27.
PubMed 31471280Kulvatunyou N, Heard SO, Bankey PE. A subclavian artery injury, secondary to internal jugular vein cannulation, is a predictable right-sided phenomenon. Anesth Analg. 2002 Sep;95(3):564-6, table of contents. doi: 10.1097/00000539-200209000-00012.
PubMed 12198037Oropello JM, Leibowitz AB, Manasia A, Del Guidice R, Benjamin E. Dilator-associated complications of central vein catheter insertion: possible mechanisms of injury and suggestions for prevention. J Cardiothorac Vasc Anesth. 1996 Aug;10(5):634-7. doi: 10.1016/s1053-0770(96)80142-x. No abstract available.
PubMed 8841872Adhya S, Laha SK. Central venous catheterization. N Engl J Med. 2007 Aug 30;357(9):944; author reply 944-5. No abstract available.
PubMed 17806139Safety Committee of Japanese Society of Anesthesiologists. Practical guide for safe central venous catheterization and management 2017. J Anesth. 2020 Apr;34(2):167-186. doi: 10.1007/s00540-019-02702-9. Epub 2019 Nov 30.
PubMed 31786676Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
PubMed 12919984Lim T, Ryu HG, Jung CW, Jeon Y, Bahk JH. Effect of the bevel direction of puncture needle on success rate and complications during internal jugular vein catheterization. Crit Care Med. 2012 Feb;40(2):491-4. doi: 10.1097/CCM.0b013e318232da48.
PubMed 21983370Lee YH, Kim TK, Jung YS, Cho YJ, Yoon S, Seo JH, Jeon Y, Bahk JH, Hong DM. Comparison of Needle Insertion and Guidewire Placement Techniques During Internal Jugular Vein Catheterization: The Thin-Wall Introducer Needle Technique Versus the Cannula-Over-Needle Technique. Crit Care Med. 2015 Oct;43(10):2112-6. doi: 10.1097/CCM.0000000000001167.
PubMed 26121076Kim E, Kim BG, Lim YJ, Jeon YT, Hwang JW, Kim HC, Choi YH, Park HP. A prospective randomised trial comparing insertion success rate and incidence of catheterisation-related complications for subclavian venous catheterisation using a thin-walled introducer needle or a catheter-over-needle technique. Anaesthesia. 2016 Sep;71(9):1030-6. doi: 10.1111/anae.13543. Epub 2016 Jul 11.
PubMed 27396474Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.
PubMed 30442261Teja B, Bosch NA, Diep C, Pereira TV, Mauricio P, Sklar MC, Sankar A, Wijeysundera HC, Saskin R, Walkey A, Wijeysundera DN, Wunsch H. Complication Rates of Central Venous Catheters: A Systematic Review and Meta-Analysis. JAMA Intern Med. 2024 May 1;184(5):474-482. doi: 10.1001/jamainternmed.2023.8232.
PubMed 38436976McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
PubMed 12646670Smith RN, Nolan JP. Central venous catheters. BMJ. 2013 Nov 11;347:f6570. doi: 10.1136/bmj.f6570. No abstract available.
PubMed 24217269
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Central Venous Puncture Dilation and Non Dilation on the Success Rate of Catheterization
- ClinicalTrials.gov ID
- NCT06652191
- Acronym / sponsor ID
- NDCVC-01 / 2024ZSLYEC-387
- Keywords
- non-dilation, central venous catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Oct 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
The central venous catheter is widely used and used in high dosage, and various complications such as hematoma, hemopneumothorax and arterial puncture may occur during puncture and use. In addition to conventional techniques, studies have been done to improve the success rate of puncture and reduce the incidence of complications by modifying different procedures. However, among the complications caused by the procedure of percutaneous catheter placement, the fatal bleeding caused by skin dilation may threaten the patient' s life. There are few studies on dilators and skin dilation steps at home and abroad. In this study, the conventional puncture technique was improved and the skin dilation step was omitted, hoping to reduce complications, reduce puncture time, improve efficiency and improve patient comfort on the premise of ensuring the success rate of catheterization.
Detailed description
The Central venous catheter is widely used, but there are various complications. During the procedure of skin expansion with central venous catheterization, the use of a dilator can lead to complications such as hematoma, fatal bleeding, discomfort or serious threat to the patient's life. The aim of this study was to eliminate the procedure of skin expansion, to ensure the success rate of catheterization, to reduce complications, to reduce operation time, to improve efficiency, and to improve patients' comfort.
This study is a single-center, prospective, randomized controlled trial.The sample size was calculated by non-inferiority test:(1)the success rate of central venous catheterization was 97.98% according to Meta-analysis references;(2)α =0.025;(3)power 90%;(4)missed follow-up rate 20%, and ultimately 336 samples were included in the study,168 patients in each group.
Patients will receive written and verbal information about the trial before written consent is obtained. Randomization will take place on the day of surgery, and patients will be assigned to the intervention group (direct catheterization with non-dilation) or the control group (catheterization after expanding the skin with a dilator) . The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a research assistant.
Under ultrasound guidance, The patient will undergo central venous catheterization by an experienced anesthesiologist based on grouping information.In the control group, catheter was inserted after skin expansion with dilator, while in the test group, catheter was inserted directly with non-dilator.The success rate of catheterization, the total time of catheterization, and complications were recorded.The patients were followed up for 24 hours after surgery and asked about their comfort level.
Shapiro-Wilk test is used to test normality for continuous variables, with data expressed as mean ± standard deviation, and independent t-test is used for statistical analysis.For categorical data, the incidence of immediate complications is expressed as a percentage (%), and chi square test is used to statistically analyze the incidence of various complications.For the Primary outcome ,success rate of catheterization, the method of confidence interval is used. If the lower limit of confidence interval > negative non-inferiority threshold, the non-inferiority is considered. P < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The test group:Direct catheterization with non-dilation | Experimental | Procedure: Direct catheterization with non-dilationUnder the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, place the catheter into the vessel directly along the guide wire without using an dilator to expand the skin |
| The control group: Catheterization after expanding the skin with a dilator | Active comparator | Procedure: Catheterization after expanding the skin with a dilatorUnder the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, after the skin is expanded with a dilator, the catheter is inserted into the vessel along the guide wire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1) patients aged 18 years or older
- (2) patients with internal jugular vein catheterization
Key exclusion criteria (4 listed)
- （1）Patients with infection at the puncture site
- （2）Patients with contraindications to central venous catheterization
- （3）Patients with imaging examination suggesting thrombosis in the internal jugular vein before puncture
- （4）Patients who refused to participate, did not sign or refused to 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 |
|---|---|---|
| Direct catheterization with non-dilationUnder the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, place the catheter into the vessel directly along the guide wire without using an dilator to expand the skin | Procedure or surgery | The test group:Direct catheterization with non-dilation |
| Catheterization after expanding the skin with a dilatorUnder the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, after the skin is expanded with a dilator, the catheter is inserted into the vessel along the guide wire | Procedure or surgery | The control group: Catheterization after expanding the skin with a dilator |
Primary outcome
Success Rate of Catheterization
Time frame: Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)
The ratio of the number of successful catheterization to the number of participants in each group. Confirm that the catheter in the target vessel is defined as:(1)The syringe smoothly draws back blood;(2)After the fluid is connected, the infusion drops flow smoothly
3 secondary outcomes
Total time of catheterization
Time frame: Intraoperative (Start with the tip of the needle touching the skin until the catheter is in the target) vessel
Incidence of immediate complications
Time frame: Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)
Patient Comfort Score
Time frame: 24 hours after catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Results publicationiData Research. Central Venous Catheter Market Size, Share & Trends Analysis, Global, 2020-2026. 2020. Accessed October 26, 2023
- Results publication秦志均,等.改良中心静脉穿刺术对穿刺置管并发症的影响.现代临床医学2016( 04) :023
- Results publication: PubMed 31471280Collier PE. Prevention and treatment of dilator injuries during central venous catheter placement. J Vasc Surg Venous Lymphat Disord. 2019 Nov;7(6):789-792. doi: 10.1016/j.jvsv.2019.06.020. Epub 2019 Aug 27.
- Results publication: PubMed 12198037Kulvatunyou N, Heard SO, Bankey PE. A subclavian artery injury, secondary to internal jugular vein cannulation, is a predictable right-sided phenomenon. Anesth Analg. 2002 Sep;95(3):564-6, table of contents. doi: 10.1097/00000539-200209000-00012.
- Results publication: PubMed 8841872Oropello JM, Leibowitz AB, Manasia A, Del Guidice R, Benjamin E. Dilator-associated complications of central vein catheter insertion: possible mechanisms of injury and suggestions for prevention. J Cardiothorac Vasc Anesth. 1996 Aug;10(5):634-7. doi: 10.1016/s1053-0770(96)80142-x. No abstract available.
- Results publication: PubMed 17806139Adhya S, Laha SK. Central venous catheterization. N Engl J Med. 2007 Aug 30;357(9):944; author reply 944-5. No abstract available.
- Results publication: PubMed 31786676Safety Committee of Japanese Society of Anesthesiologists. Practical guide for safe central venous catheterization and management 2017. J Anesth. 2020 Apr;34(2):167-186. doi: 10.1007/s00540-019-02702-9. Epub 2019 Nov 30.
- Results publication: PubMed 12919984Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
- Results publication: PubMed 21983370Lim T, Ryu HG, Jung CW, Jeon Y, Bahk JH. Effect of the bevel direction of puncture needle on success rate and complications during internal jugular vein catheterization. Crit Care Med. 2012 Feb;40(2):491-4. doi: 10.1097/CCM.0b013e318232da48.
- Results publication: PubMed 26121076Lee YH, Kim TK, Jung YS, Cho YJ, Yoon S, Seo JH, Jeon Y, Bahk JH, Hong DM. Comparison of Needle Insertion and Guidewire Placement Techniques During Internal Jugular Vein Catheterization: The Thin-Wall Introducer Needle Technique Versus the Cannula-Over-Needle Technique. Crit Care Med. 2015 Oct;43(10):2112-6. doi: 10.1097/CCM.0000000000001167.
- Results publication: PubMed 27396474Kim E, Kim BG, Lim YJ, Jeon YT, Hwang JW, Kim HC, Choi YH, Park HP. A prospective randomised trial comparing insertion success rate and incidence of catheterisation-related complications for subclavian venous catheterisation using a thin-walled introducer needle or a catheter-over-needle technique. Anaesthesia. 2016 Sep;71(9):1030-6. doi: 10.1111/anae.13543. Epub 2016 Jul 11.
- Results publication: PubMed 30442261Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.
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.
Sanqing Jin, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct catheterization with non-dilation and Catheterization after expanding the skin with a dilator in people with the Success Rate of Non Dilation on the Central Venous Catheterization, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanqing Jin, MD (0086-13719366863, sanqingjin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Catheterization (time frame: Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652191, which also lists 15 linked publications.
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 Oct 2024.