NeoplasmsPREMONCT03948958
PREMO Study: to Investigate Port REMoval Outcomes
A study testing Evaluation of the catheter function, Catheter tip location, thrombus, sleeve and device damage visualization and Catheter-related colonization in people with Neoplasms and Cystic Fibrosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Cystic Fibrosis
- What is being tested?
- Evaluation of the catheter function, Catheter tip location, thrombus, sleeve and device damage visualization and Catheter-related colonization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jun 2019to 8 Jul 2022
- 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
- Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment.
- Patients planned for an elective TIVAD removal under local anaesthesia.
- Patients able to participate in the study and willing to sign an informed consent.
- Patients able to understand and read Dutch.
Who cannot join
- History of fever and/or chills following last flushing procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)
A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.
Read the detailed description
A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure.
Clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year.
This exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy.
- Conditions
- Neoplasms, Cystic Fibrosis
- Being tested
- Evaluation of the catheter function, Catheter tip location, thrombus, sleeve and device damage visualization, Catheter-related colonization, patient-reported outcome measures (PROM) related to the presence of the TIVAD, Macroscopic evaluation of the port chamber and catheter
- Keywords
- Vascular Access Devices, Implantable port, Flush interval, Catheter function, Catheter-related infection, Catheter tip location, Catheter tip thrombus, Catheter sleeve, Patient-reported outcome measure
- Medical subject headings
- Neoplasms, Cystic Fibrosis, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the catheter functionOther
Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)
Catheter tip location, thrombus, sleeve and device damage visualizationOther
Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram
Catheter-related colonizationOther
TIVAD colonization will be investigated by microbiological culture of the tip and chamber content
patient-reported outcome measures (PROM) related to the presence of the TIVADOther
PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.
Macroscopic evaluation of the port chamber and catheterOther
Macroscopic evaluation of the port chamber and catheter will be performed after port removal.
| Study group | Role | What they receive |
|---|---|---|
| TIVAD evaluation | Experimental | TIVAD evaluation at port removal evaluation of catheter function, visualization of catheter tip, presence of thrombus material and sleeve and any device damage during linogram (contrast injection via TIVAD), tip and chamber content microbiological culture, macroscopic catheter and port chamber evaluation PROM: patient reported outcome measurements regarding TIVAD insertion, presence and removal Receives: Other: Evaluation of the catheter function; Other: Catheter tip location, thrombus, sleeve and device damage visualization; Other: Catheter-related colonization; Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD; Other: Macroscopic evaluation of the port chamber and catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIVAD function
will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification.
Measured: during the 1 day of TIVAD removal, before the linogram
Secondary outcomes (3)
Catheter tip position visualization by fluoroscopy
The patient will be positioned in a nearly standing position with chest elevation of 17°
Measured: during the 1 day of TIVAD removal, just before the linogram
Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory
will be visualised by linogram (digital substraction angiography)
Measured: during the 1 day of TIVAD removal
Catheter tip and port chamber culture
microbial culture
Measured: during the 1 day of TIVAD removal (following TIVAD removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start28 Jun 2019
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Medical SA
- Responsible party
- Principal investigator, Stas Marguerite, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Marguerite Stas, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948958
- Sponsor's protocol ID
- S62321
- Acronym
- PREMO
- Status last verified
- Aug 2022
- First submitted
- 10 May 2019
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goossens GA, Jerome M, Janssens C, Peetermans WE, Fieuws S, Moons P, Verschakelen J, Peerlinck K, Jacquemin M, Stas M. Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial. Ann Oncol. 2013 Jul;24(7):1892-1899. doi: 10.1093/annonc/mdt114. Epub 2013 Apr 3.
PubMed 23553060Odabas H, Ozdemir NY, Ziraman I, Aksoy S, Abali H, Oksuzoglu B, Isik M, Civelek B, Dede D, Zengin N. Effect of port-care frequency on venous port catheter-related complications in cancer patients. Int J Clin Oncol. 2014 Aug;19(4):761-6. doi: 10.1007/s10147-013-0609-7. Epub 2013 Aug 27.
PubMed 23978939Palese A, Baldassar D, Rupil A, Bonanni G, Capellari Maria T, Contessi D, De Crignis L, Vidoni A, Piller Roner S, Zanini A. Maintaining patency in totally implantable venous access devices (TIVAD): a time-to-event analysis of different lock irrigation intervals. Eur J Oncol Nurs. 2014 Feb;18(1):66-71. doi: 10.1016/j.ejon.2013.09.002. Epub 2013 Oct 4.
PubMed 24100090Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.
PubMed 28084883Dal Molin A, Guerretta L, Mazzufero F, Rasero L. The management of totally implanted venous ports in the ambulatory oncologic patient. J Vasc Access. 2009 Jan-Mar;10(1):22-6. doi: 10.1177/112972980901000104.
PubMed 19340795Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.
PubMed 26075094Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.
PubMed 25404862Gristina AG, Giridhar G, Gabriel BL, Naylor PT, Myrvik QN. Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs. 1993 Nov;16(11):755-63.
PubMed 8150521Douard MC, Arlet G, Longuet P, Troje C, Rouveau M, Ponscarme D, Eurin B. Diagnosis of venous access port-related infections. Clin Infect Dis. 1999 Nov;29(5):1197-202. doi: 10.1086/313444.
PubMed 10524963Brouns F, Schuermans A, Verhaegen J, De Wever I, Stas M. Infection assessment of totally implanted long-term venous access devices. J Vasc Access. 2006 Jan-Mar;7(1):24-8. doi: 10.1177/112972980600700105.
PubMed 16596525Tang S, Beigel R, Arsanjani R, Larson B, Luthringer D, Siegel R. Infective Endovascular Fibrin Sheath Vegetations-A New Cause of Bacteremia Detected by Transesophageal Echocardiogram. Am J Med. 2015 Sep;128(9):1029-38. doi: 10.1016/j.amjmed.2015.03.019. Epub 2015 Apr 10.
PubMed 25865922Onal B, Coskun B, Karabulut R, Ilgit ET, Turkyilmaz Z, Sonmez K. Interventional radiological retrieval of embolized vascular access device fragments. Diagn Interv Radiol. 2012 Jan-Feb;18(1):87-91. doi: 10.4261/1305-3825.DIR.4098-10.1. Epub 2011 Feb 8.
PubMed 21305467Kojima S, Hiraki T, Gobara H, Iguchi T, Fujiwara H, Matsui Y, Mitsuhashi T, Kanazawa S. Fracture of totally implanted central venous access devices: a propensity-score-matched comparison of risks for Groshong silicone versus polyurethane catheters. J Vasc Access. 2016 Nov 2;17(6):535-541. doi: 10.5301/jva.5000606. Epub 2016 Oct 21.
PubMed 27768210Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26.
PubMed 26209949Bouza E, Martin-Rabadan P, Echenagusia A, Camunez F, Rodriguez-Rosales G, Simo G, Echenagusia M, Guembe M; GEIDI study group. Diagnosis of venous access port colonization requires cultures from multiple sites: should guidelines be amended? Diagn Microbiol Infect Dis. 2014 Feb;78(2):162-7. doi: 10.1016/j.diagmicrobio.2013.11.004. Epub 2013 Nov 14.
PubMed 24316016
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)
- ClinicalTrials.gov ID
- NCT03948958
- Acronym / sponsor ID
- PREMO / S62321
- Conditions
- Neoplasms, Cystic Fibrosis
- Keywords
- Vascular Access Devices, Implantable port, Flush interval, Catheter function, Catheter-related infection, Catheter tip location, Catheter tip thrombus, Catheter sleeve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- B. Braun Medical SA
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 14 May 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.
A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.
Detailed description
A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure.
Clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year.
This exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIVAD evaluation | Experimental | Other: Evaluation of the catheter function, Other: Catheter tip location, thrombus, sleeve and device damage visualization, Other: Catheter-related colonization, Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD, Other: Macroscopic evaluation of the port chamber and catheterTIVAD evaluation at port removal evaluation of catheter function, visualization of catheter tip, presence of thrombus material and sleeve and any device damage during linogram (contrast injection via TIVAD), tip and chamber content microbiological culture, macroscopic catheter and port chamber evaluation PROM: patient reported outcome measurements regarding TIVAD insertion, presence and removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment.
- Patients planned for an elective TIVAD removal under local anaesthesia.
- Patients able to participate in the study and willing to sign an informed consent.
- Patients able to understand and read Dutch.
Key exclusion criteria (1 listed)
- History of fever and/or chills following last flushing procedure
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 |
|---|---|---|
| Evaluation of the catheter functionCatheter function will be measured by the CINAS (Catheter injection and aspiration classification) | Other | TIVAD evaluation |
| Catheter tip location, thrombus, sleeve and device damage visualizationCatheter tip location, thrombus, sleeve and device damage will be visualized by linogram | Other | TIVAD evaluation |
| Catheter-related colonizationTIVAD colonization will be investigated by microbiological culture of the tip and chamber content | Other | TIVAD evaluation |
| patient-reported outcome measures (PROM) related to the presence of the TIVADPROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire. | Other | TIVAD evaluation |
| Macroscopic evaluation of the port chamber and catheterMacroscopic evaluation of the port chamber and catheter will be performed after port removal. | Other | TIVAD evaluation |
Primary outcome
TIVAD function
Time frame: during the 1 day of TIVAD removal, before the linogram
will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification.
3 secondary outcomes
Catheter tip position visualization by fluoroscopy
Time frame: during the 1 day of TIVAD removal, just before the linogram
Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory
Time frame: during the 1 day of TIVAD removal
Catheter tip and port chamber culture
Time frame: during the 1 day of TIVAD removal (following TIVAD removal)
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 12 Aug 2022.
- Background: PubMed 23553060Goossens GA, Jerome M, Janssens C, Peetermans WE, Fieuws S, Moons P, Verschakelen J, Peerlinck K, Jacquemin M, Stas M. Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial. Ann Oncol. 2013 Jul;24(7):1892-1899. doi: 10.1093/annonc/mdt114. Epub 2013 Apr 3.
- Background: PubMed 23978939Odabas H, Ozdemir NY, Ziraman I, Aksoy S, Abali H, Oksuzoglu B, Isik M, Civelek B, Dede D, Zengin N. Effect of port-care frequency on venous port catheter-related complications in cancer patients. Int J Clin Oncol. 2014 Aug;19(4):761-6. doi: 10.1007/s10147-013-0609-7. Epub 2013 Aug 27.
- Background: PubMed 24100090Palese A, Baldassar D, Rupil A, Bonanni G, Capellari Maria T, Contessi D, De Crignis L, Vidoni A, Piller Roner S, Zanini A. Maintaining patency in totally implantable venous access devices (TIVAD): a time-to-event analysis of different lock irrigation intervals. Eur J Oncol Nurs. 2014 Feb;18(1):66-71. doi: 10.1016/j.ejon.2013.09.002. Epub 2013 Oct 4.
- Background: PubMed 28084883Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.
- Background: PubMed 19340795Dal Molin A, Guerretta L, Mazzufero F, Rasero L. The management of totally implanted venous ports in the ambulatory oncologic patient. J Vasc Access. 2009 Jan-Mar;10(1):22-6. doi: 10.1177/112972980901000104.
- Background: PubMed 26075094Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.
- Background: PubMed 25404862Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.
- Background: PubMed 8150521Gristina AG, Giridhar G, Gabriel BL, Naylor PT, Myrvik QN. Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs. 1993 Nov;16(11):755-63.
- Background: PubMed 10524963Douard MC, Arlet G, Longuet P, Troje C, Rouveau M, Ponscarme D, Eurin B. Diagnosis of venous access port-related infections. Clin Infect Dis. 1999 Nov;29(5):1197-202. doi: 10.1086/313444.
- Background: PubMed 16596525Brouns F, Schuermans A, Verhaegen J, De Wever I, Stas M. Infection assessment of totally implanted long-term venous access devices. J Vasc Access. 2006 Jan-Mar;7(1):24-8. doi: 10.1177/112972980600700105.
- Background: PubMed 25865922Tang S, Beigel R, Arsanjani R, Larson B, Luthringer D, Siegel R. Infective Endovascular Fibrin Sheath Vegetations-A New Cause of Bacteremia Detected by Transesophageal Echocardiogram. Am J Med. 2015 Sep;128(9):1029-38. doi: 10.1016/j.amjmed.2015.03.019. Epub 2015 Apr 10.
- Background: PubMed 21305467Onal B, Coskun B, Karabulut R, Ilgit ET, Turkyilmaz Z, Sonmez K. Interventional radiological retrieval of embolized vascular access device fragments. Diagn Interv Radiol. 2012 Jan-Feb;18(1):87-91. doi: 10.4261/1305-3825.DIR.4098-10.1. Epub 2011 Feb 8.
- Individual participant dataSharing planned: No
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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.
Marguerite Stas, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the catheter function, Catheter tip location, thrombus, sleeve and device damage visualization and Catheter-related colonization in people with Neoplasms and Cystic Fibrosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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 12 Aug 2022. 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 Belgium. 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?
TIVAD function (time frame: during the 1 day of TIVAD removal, before the linogram). 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 NCT03948958, 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 12 Aug 2022.