Ductus Arteriosus, PatentNCT04205877
The U.S. PDA Registry
An observational study of Ductus Arteriosus, Patent, run by Le Bonheur Children's Hospital at 1 site in United States.
Trial summary
The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA. Read more about this study
- Who is it for?
- Ages 3 days to 1 year
- Conditions the study is for
- Ductus Arteriosus, Patent
- What is being tested?
- Transcatheter PDA Closure
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 days to 1 year
- All sexes
- Child
Study population: The study population is patients with diagnosis of PDA with clinical indication for transcatheter PDA closure, and weigh less than 2 kg at the time of device implant.
Who may be able to join
- Diagnosis of PDA.
- Clinical indication for transcatheter PDA closure (discretion of the physician).
- Weight <2 kg at the time of device implant.
Who cannot join
- Weight <700 gm or greater than or equal to 2 kg at the time of device implant.
- Age < 3 days at the time of device implant.
- Pre-existing coarctation of the aorta.
- Pre-existing left pulmonary artery stenosis.
- Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.
- Intracardiac thrombus that interferes with device implant.
- Active infection requiring treatment at the time of impant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Shyam K Sathanandam, MD, 901-287-6380, ssathan@uthsc.edu
Jorden Cunningham, BSN, 901-287-7457, jorden.cunningham@lebonheur.org
About this study
Official title: The United States Patent Ductus Arteriosus Registry
The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA.
Read the detailed description
Based on the IMPACT registry, there are over 6000 transcatheter device closures of PDA that occurs in the United States annually. However, there are no comprehensive data collection tools for this procedure. The current databases do not include multiple data points, or follow-up data, or a section for specific adverse events to be documented. Moreover, until now, there has been no approved devices for PDA closure in children < 2kg. This clinical study is the first of its kind to collect data from all transcatheter device closure of PDA in children < 2kg performed in the USA.This study will be limited to children between 700 to 2000 grams who are the most vulnerable population undergoing this procedure. This will allow us to understand the real world experience (efficacy and safety) of using the Amplatzer Piccolo Occluder and other devices in an extremely vulnerable, yet highly underserved population. The study will allow for standardization of this procedure throughout the country for the small children (<2 kg) with a PDA. This is a multi-center, single arm, observational data collection study. This will be a large population study to help analyze outcomes in subjects <2 kg. The trial has two primary endpoints for safety and effectiveness without formal hypothesis. The safety and effectiveness results will be compared with data reported in the ADO II AS IDE and Continued Access Protocol studies.
- Conditions
- Ductus Arteriosus, Patent
- Being tested
- Transcatheter PDA Closure
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter PDA ClosureDevice
Device utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant.
| Study group | Role | What they receive |
|---|---|---|
| Registry Group | All participants will have the same data collected at the same time points. Receives: Device: Transcatheter PDA Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Access Complications (Safety)
Access vessel complications include femoral arterial or femoral/jugular venous complications noted during the procedure, immediately after the procedure or delayed (>24 hours). They range from bleeding from access sites, arterial or venous thrombosis with or without the need for treatment to loss of limb secondary to arterial occlusion.
Measured: 6 months
Valvular Injury (Safety)
Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.
Measured: 6 months
Device Embolization (Safety)
Device embolization includes malposition of the device either during or after the procedure or delayed (>24 hours). The outcome of device embolization ranges from observation, transcatheter retrieval at time of procedure or at a separate time, surgical retrieval, other end organ damage, to mortality.
Measured: 6 months
Pulmonary or Aortic Vessel Stenosis (Safety)
Adjacent vessel stenosis includes a narrowing of the aorta or the left pulmonary artery directly as a consequence of device implantation for PDA closure. Vessel stenosis could happen either during or after the procedure or delayed (>24 hours). The outcome of vessel stenosis ranges from no intervention needed to repeated transcatheter and surgical therapies.
Measured: 6 months
Rate of Effective PDA Closure (Effectiveness)
The effectiveness endpoint is the rate of effective closure of the PDA using a transcatheter device within six months post procedure. If more than one attempt is required, or multiple devices are required during the same procedure, it is still considered effective if there is Grade 0 or Grade 1 shunt, as defined below, at follow-up by transthoracic echocardiography or if a second procedure is not required following the initial attempt. If there is device embolization, adjacent vessel stenosis that required retrieval of the device and replacement during the same procedure with less than Grade 1 shunt during follow-up, it is still considered effective. Conversely, if an AE is noted after the procedure that requires a second procedure for treatment that results in greater than Grade 1 shunt, then the procedure is considered not effective, even if the initial attempt was effective. See protocol for PDA shunt definitions.
Measured: 6 months
Secondary outcomes (2)
Significant obstruction of the left pulmonary artery
Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery
≥35 mmHg by echocardiogram if lung perfusion scan is not available or as determined by the interventional cardiologist based on angiographic appearance.
Measured: 6 months
Significant obstruction of the aorta
Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Ductus Arteriosus, PatentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Le Bonheur Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Shyam K. Sathanandam, MD, Le Bonheur Children's Hospital
- Investigators
- Shyam Sathanandam, MD, Principal investigator, National Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205877
- Sponsor's protocol ID
- The U.S. PDA Registry
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A Data Management Plan (DMP) will describe procedures used for data review, database cleaning, and issuing and resolving data queries. If appropriate, the DMP may be updated throughout the clinical investigation duration. All revisions will be tracked and document controlled. Subject data will be captured in a validated electronic data capture (EDC) system. Only authorized site personnel will be permitted to enter the CRF data through the EDC system. An electronic audit trail will be used to track any subsequent changes of the entered data.
Publications
Tashiro J, Perez EA, Sola JE. Reduced Hospital Mortality With Surgical Ligation of Patent Ductus Arteriosus in Premature, Extremely Low Birth Weight Infants: A Propensity Score-matched Outcome Study. Ann Surg. 2016 Mar;263(3):608-14. doi: 10.1097/SLA.0000000000001228.
PubMed 25822689Schneider DJ. The patent ductus arteriosus in term infants, children, and adults. Semin Perinatol. 2012 Apr;36(2):146-53. doi: 10.1053/j.semperi.2011.09.025.
PubMed 22414886Mahoney LT, Coryell KG, Lauer RM. The newborn transitional circulation: a two-dimensional Doppler echocardiographic study. J Am Coll Cardiol. 1985 Sep;6(3):623-9. doi: 10.1016/s0735-1097(85)80123-6.
PubMed 4031274Philip R, Waller BR 3rd, Agrawal V, Wright D, Arevalo A, Zurakowski D, Sathanandam S. Morphologic characterization of the patent ductus arteriosus in the premature infant and the choice of transcatheter occlusion device. Catheter Cardiovasc Interv. 2016 Feb 1;87(2):310-7. doi: 10.1002/ccd.26287. Epub 2015 Nov 3.
PubMed 26525611Krichenko A, Benson LN, Burrows P, Moes CA, McLaughlin P, Freedom RM. Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol. 1989 Apr 1;63(12):877-80. doi: 10.1016/0002-9149(89)90064-7. No abstract available.
PubMed 2929450Pass RH. Amplatzer Duct Occluder device: a new technology for the closure of the moderate-to-large-sized patent ductus arteriosus. Expert Rev Med Devices. 2006 May;3(3):291-6. doi: 10.1586/17434440.3.3.291.
PubMed 16681450Moore JW, Levi DS, Moore SD, Schneider DJ, Berdjis F. Interventional treatment of patent ductus arteriosus in 2004. Catheter Cardiovasc Interv. 2005 Jan;64(1):91-101. doi: 10.1002/ccd.20243.
PubMed 15619281Perlo f, Joseph K.The Clinical Recognition of Congenital Heart Disease. Philadelphia: Saunders. Print.
Gross RE, Hubbard JP. Landmark article Feb 25, 1939: Surgical ligation of a patent ductus arteriosus. Report of first successful case. By Robert E. Gross and John P. Hubbard. JAMA. 1984 Mar 2;251(9):1201-2. doi: 10.1001/jama.251.9.1201. No abstract available.
PubMed 6363741Kabra NS, Schmidt B, Roberts RS, Doyle LW, Papile L, Fanaroff A; Trial of Indomethacin Prophylaxis in Preterms Investigators. Neurosensory impairment after surgical closure of patent ductus arteriosus in extremely low birth weight infants: results from the Trial of Indomethacin Prophylaxis in Preterms. J Pediatr. 2007 Mar;150(3):229-34, 234.e1. doi: 10.1016/j.jpeds.2006.11.039.
PubMed 17307535Chorne N, Leonard C, Piecuch R, Clyman RI. Patent ductus arteriosus and its treatment as risk factors for neonatal and neurodevelopmental morbidity. Pediatrics. 2007 Jun;119(6):1165-74. doi: 10.1542/peds.2006-3124.
PubMed 17545385Teixeira LS, Shivananda SP, Stephens D, Van Arsdell G, McNamara PJ. Postoperative cardiorespiratory instability following ligation of the preterm ductus arteriosus is related to early need for intervention. J Perinatol. 2008 Dec;28(12):803-10. doi: 10.1038/jp.2008.101. Epub 2008 Jul 10.
PubMed 18615091Porstmann W, Wierny L, Warnke H, Gerstberger G, Romaniuk PA. Catheter closure of patent ductus arteriosus. 62 cases treated without thoracotomy. Radiol Clin North Am. 1971 Aug;9(2):203-18. No abstract available.
PubMed 4938290Weisz DE, McNamara PJ. Patent ductus arteriosus ligation and adverse outcomes: causality or bias? J Clin Neonatol. 2014 Apr;3(2):67-75. doi: 10.4103/2249-4847.134670.
PubMed 25024972Gruenstein DH, Ebeid M, Radtke W, Moore P, Holzer R, Justino H. Transcatheter closure of patent ductus arteriosus using the AMPLATZER duct occluder II (ADO II). Catheter Cardiovasc Interv. 2017 May;89(6):1118-1128. doi: 10.1002/ccd.26968. Epub 2017 Mar 4.
PubMed 28258658
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The United States Patent Ductus Arteriosus Registry
- ClinicalTrials.gov ID
- NCT04205877
- Acronym / sponsor ID
- The U.S. PDA Registry
- Conditions
- Ductus Arteriosus, Patent
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 20 Dec 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.
The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA.
Detailed description
Based on the IMPACT registry, there are over 6000 transcatheter device closures of PDA that occurs in the United States annually. However, there are no comprehensive data collection tools for this procedure. The current databases do not include multiple data points, or follow-up data, or a section for specific adverse events to be documented. Moreover, until now, there has been no approved devices for PDA closure in children < 2kg. This clinical study is the first of its kind to collect data from all transcatheter device closure of PDA in children < 2kg performed in the USA.This study will be limited to children between 700 to 2000 grams who are the most vulnerable population undergoing this procedure. This will allow us to understand the real world experience (efficacy and safety) of using the Amplatzer Piccolo Occluder and other devices in an extremely vulnerable, yet highly underserved population. The study will allow for standardization of this procedure throughout the country for the small children (<2 kg) with a PDA. This is a multi-center, single arm, observational data collection study. This will be a large population study to help analyze outcomes in subjects <2 kg. The trial has two primary endpoints for safety and effectiveness without formal hypothesis. The safety and effectiveness results will be compared with data reported in the ADO II AS IDE and Continued Access Protocol studies.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry Group | – | Device: Transcatheter PDA ClosureAll participants will have the same data collected at the same time points. |
Who may qualify
- Ages
- 3 days to 1 year
- Sex
- All
- Age groups
- Child
- Study population
- The study population is patients with diagnosis of PDA with clinical indication for transcatheter PDA closure, and weigh less than 2 kg at the time of device implant.
Key inclusion criteria (3 listed)
- Diagnosis of PDA.
- Clinical indication for transcatheter PDA closure (discretion of the physician).
- Weight <2 kg at the time of device implant.
Key exclusion criteria (7 listed)
- Weight <700 gm or greater than or equal to 2 kg at the time of device implant.
- Age < 3 days at the time of device implant.
- Pre-existing coarctation of the aorta.
- Pre-existing left pulmonary artery stenosis.
- Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.
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 |
|---|---|---|
| Transcatheter PDA ClosureDevice utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant. | Device | Registry Group |
Primary outcome
Vascular Access Complications (Safety)
Time frame: 6 months
Access vessel complications include femoral arterial or femoral/jugular venous complications noted during the procedure, immediately after the procedure or delayed (>24 hours). They range from bleeding from access sites, arterial or venous thrombosis with or without the need for treatment to loss of limb secondary to arterial occlusion.
Valvular Injury (Safety)
Time frame: 6 months
Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.
Device Embolization (Safety)
Time frame: 6 months
Device embolization includes malposition of the device either during or after the procedure or delayed (>24 hours). The outcome of device embolization ranges from observation, transcatheter retrieval at time of procedure or at a separate time, surgical retrieval, other end organ damage, to mortality.
Pulmonary or Aortic Vessel Stenosis (Safety)
Time frame: 6 months
Adjacent vessel stenosis includes a narrowing of the aorta or the left pulmonary artery directly as a consequence of device implantation for PDA closure. Vessel stenosis could happen either during or after the procedure or delayed (>24 hours). The outcome of vessel stenosis ranges from no intervention needed to repeated transcatheter and surgical therapies.
Rate of Effective PDA Closure (Effectiveness)
Time frame: 6 months
The effectiveness endpoint is the rate of effective closure of the PDA using a transcatheter device within six months post procedure. If more than one attempt is required, or multiple devices are required during the same procedure, it is still considered effective if there is Grade 0 or Grade 1 shunt, as defined below, at follow-up by transthoracic echocardiography or if a second procedure is not required following the initial attempt. If there is device embolization, adjacent vessel stenosis that required retrieval of the device and replacement during the same procedure with less than Grade 1 shunt during follow-up, it is still considered effective. Conversely, if an AE is noted after the procedure that requires a second procedure for treatment that results in greater than Grade 1 shunt, then the procedure is considered not effective, even if the initial attempt was effective. See protocol for PDA shunt definitions.
2 secondary outcomes
Significant obstruction of the left pulmonary artery
Time frame: 6 months
Significant obstruction of the aorta
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Results publication: PubMed 25822689Tashiro J, Perez EA, Sola JE. Reduced Hospital Mortality With Surgical Ligation of Patent Ductus Arteriosus in Premature, Extremely Low Birth Weight Infants: A Propensity Score-matched Outcome Study. Ann Surg. 2016 Mar;263(3):608-14. doi: 10.1097/SLA.0000000000001228.
- Results publication: PubMed 22414886Schneider DJ. The patent ductus arteriosus in term infants, children, and adults. Semin Perinatol. 2012 Apr;36(2):146-53. doi: 10.1053/j.semperi.2011.09.025.
- Results publication: PubMed 4031274Mahoney LT, Coryell KG, Lauer RM. The newborn transitional circulation: a two-dimensional Doppler echocardiographic study. J Am Coll Cardiol. 1985 Sep;6(3):623-9. doi: 10.1016/s0735-1097(85)80123-6.
- Results publication: PubMed 26525611Philip R, Waller BR 3rd, Agrawal V, Wright D, Arevalo A, Zurakowski D, Sathanandam S. Morphologic characterization of the patent ductus arteriosus in the premature infant and the choice of transcatheter occlusion device. Catheter Cardiovasc Interv. 2016 Feb 1;87(2):310-7. doi: 10.1002/ccd.26287. Epub 2015 Nov 3.
- Results publication: PubMed 2929450Krichenko A, Benson LN, Burrows P, Moes CA, McLaughlin P, Freedom RM. Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol. 1989 Apr 1;63(12):877-80. doi: 10.1016/0002-9149(89)90064-7. No abstract available.
- Results publication: PubMed 16681450Pass RH. Amplatzer Duct Occluder device: a new technology for the closure of the moderate-to-large-sized patent ductus arteriosus. Expert Rev Med Devices. 2006 May;3(3):291-6. doi: 10.1586/17434440.3.3.291.
- Results publication: PubMed 15619281Moore JW, Levi DS, Moore SD, Schneider DJ, Berdjis F. Interventional treatment of patent ductus arteriosus in 2004. Catheter Cardiovasc Interv. 2005 Jan;64(1):91-101. doi: 10.1002/ccd.20243.
- Results publicationPerlo f, Joseph K.The Clinical Recognition of Congenital Heart Disease. Philadelphia: Saunders. Print.
- Results publication: PubMed 6363741Gross RE, Hubbard JP. Landmark article Feb 25, 1939: Surgical ligation of a patent ductus arteriosus. Report of first successful case. By Robert E. Gross and John P. Hubbard. JAMA. 1984 Mar 2;251(9):1201-2. doi: 10.1001/jama.251.9.1201. No abstract available.
- Results publication: PubMed 17307535Kabra NS, Schmidt B, Roberts RS, Doyle LW, Papile L, Fanaroff A; Trial of Indomethacin Prophylaxis in Preterms Investigators. Neurosensory impairment after surgical closure of patent ductus arteriosus in extremely low birth weight infants: results from the Trial of Indomethacin Prophylaxis in Preterms. J Pediatr. 2007 Mar;150(3):229-34, 234.e1. doi: 10.1016/j.jpeds.2006.11.039.
- Results publication: PubMed 17545385Chorne N, Leonard C, Piecuch R, Clyman RI. Patent ductus arteriosus and its treatment as risk factors for neonatal and neurodevelopmental morbidity. Pediatrics. 2007 Jun;119(6):1165-74. doi: 10.1542/peds.2006-3124.
- Results publication: PubMed 18615091Teixeira LS, Shivananda SP, Stephens D, Van Arsdell G, McNamara PJ. Postoperative cardiorespiratory instability following ligation of the preterm ductus arteriosus is related to early need for intervention. J Perinatol. 2008 Dec;28(12):803-10. doi: 10.1038/jp.2008.101. Epub 2008 Jul 10.
- Individual participant dataSharing planned: Yes. A Data Management Plan (DMP) will describe procedures used for data review, database cleaning, and issuing and resolving data queries. If appropriate, the DMP may be updated throughout the clinical investigation duration. All revisions will be tracked and document controlled. Subject data will be captured in a validated electronic data capture (EDC) system. Only authorized site personnel will be permitted to enter the CRF data through the EDC system. An electronic audit trail will be used to track any subsequent changes of the entered data.
Related trials for Ductus Arteriosus, Patent
Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth
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.
Shyam Sathanandam, MD principal investigator
National Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ductus Arteriosus, Patent, run by Le Bonheur Children's Hospital at 1 site in United States.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 Dec 2019. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shyam K Sathanandam, MD (901-287-6380, ssathan@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Access Complications (Safety) (time frame: 6 months). The study lists 5 primary outcomes in all. 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 NCT04205877, which also lists 19 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 20 Dec 2019.