CKDLTHD PMCFNCT04782297
Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)
An observational study of CKD and ESRD, run by Medical Components, Inc dba MedComp at 2 sites in 2 countries.
Trial summary
The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Long term hemodialysis catheter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Mar 2022to 17 Mar 2023
- Phase
- Observational
- 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
Study population: Retrospective patients (those who already have one of the Medcomp LTHD catheters inserted) will be enrolled. Retrospective patients from the previous 36 months will be approached for participation in the study. Patients who have previously received a Medcomp LTHD catheter will also be approached for consent and assessment of eligibility.
Who may be able to join
- ≥ 18 years of age at the time of enrollment
- Patients who have previously received the Medcomp subject device or patients currently receiving hemodialysis treatment, who have had a Medcomp subject device implanted for >90 days
- Health records relevant to this study are complete and accessible by Study team at the hemodialysis center, implantation center, medical facilities where complications are treated, and by the participating Principal Investigator (PI)
- Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form
Who cannot join
- Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use
- Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Study in the opinion of the sponsor in consultation with the Principal Investigator)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Maryland School of Medicine Vascular & Interventional Radiology Department
Baltimore, Maryland, 21202
About this study
Official title: Post-Market Clinical Follow-up Study - Open Label, Consecutive Series, Observational Study on the Use of Medcomp Long Term Catheters for Hemodialysis (LTHD)
The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.
Read the detailed description
The Observational Study will enroll a target of 198 subjects across two cohorts of 89 patients per cohort, with each cohort representing one catheter type. Retrospective patients previously treated with either a Hemo-Flow or Titan HD catheter will be enrolled. The primary endpoint of this study for all device families is insertion success. For the purposes of this data, a successful insertion will be defined as the successful initiation of vascular access device insertion, as determined by the investigator.
- Being tested
- Long term hemodialysis catheter
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term hemodialysis catheterDevice
There will be no interventions in this study. Strictly observational.
| Study group | Role | What they receive |
|---|---|---|
| Titan HD Catheter | The Titan HD Catheter is a double lumen catheter that provides 2 dedicated (arterial/venous) access lumens. Each lumen is connected through an extension line with female luer connectors. The arterial and venous catheter lumens connect to a hub to facilitate connection of extension tubes with clamps intended to prevent air/fluid communication and control fluid flow through the catheter. At the proximal end of the extension tubes are female Luer fittings to provide a needleless connection. The clamps and the sleeves are color-coded red for the arterial lumen and blue for the venous lumen. Each catheter has a cuff which is intended to be positioned underneath the skin at the skin exit to aid in securing the catheter and to provide a barrier to minimize the risk of infection. Each lumen is connected through an extension line with female Luer connectors. The transition between lumen and extension is housed within a molded hub. Receives: Device: Long term hemodialysis catheter | |
| Hemo-Flow Catheter | The Hemo-Flow® Catheter has two lumens (one arterial lumen, one venous lumen) comprised of a biocompatible polymeric material that contains radiopaque filler to allow radiographic imaging of the distal tips to ensure proper placement into the superior vena cava. The arterial lumen is utilized to withdraw blood from the patient and the venous lumen returns the blood to the patient after treatment Receives: Device: Long term hemodialysis catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion Success
Successful initiation of vascular access device insertion, as determined by the investigator.
Measured: Percentage at Insertion
Secondary outcomes (1)
Adverse Events (Infection per 1000 catheter days)
Infection, Removals due to infection or thrombosis, catheter related blood stream infection (CRBSI)
Measured: 1000 catheter days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start30 Mar 2022 (estimated)
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Why it stopped: Recruitment and enrollment was not prioritized by sites and no enrollments occurred over the course of 1 year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Components, Inc dba MedComp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Veeva Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782297
- Sponsor's protocol ID
- PMCF_LTHD_201
- Acronym
- LTHD PMCF
- Status last verified
- Jan 2024
- First submitted
- 2 Mar 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study - Open Label, Consecutive Series, Observational Study on the Use of Medcomp Long Term Catheters for Hemodialysis (LTHD)
- ClinicalTrials.gov ID
- NCT04782297
- Acronym / sponsor ID
- LTHD PMCF / PMCF_LTHD_201
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment and enrollment was not prioritized by sites and no enrollments occurred over the course of 1 year.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical Components, Inc dba MedCompIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Veeva Systems
- Study start
- 30 Mar 2022 (estimated)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 4 Mar 2021 (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 primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.
Detailed description
The Observational Study will enroll a target of 198 subjects across two cohorts of 89 patients per cohort, with each cohort representing one catheter type. Retrospective patients previously treated with either a Hemo-Flow or Titan HD catheter will be enrolled. The primary endpoint of this study for all device families is insertion success. For the purposes of this data, a successful insertion will be defined as the successful initiation of vascular access device insertion, as determined by the investigator.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titan HD Catheter | – | Device: Long term hemodialysis catheterThe Titan HD Catheter is a double lumen catheter that provides 2 dedicated (arterial/venous) access lumens. Each lumen is connected through an extension line with female luer connectors. The arterial and venous catheter lumens connect to a hub to facilitate connection of extension tubes with clamps intended to prevent air/fluid communication and control fluid flow through the catheter. At the proximal end of the extension tubes are female Luer fittings to provide a needleless connection. The clamps and the sleeves are color-coded red for the arterial lumen and blue for the venous lumen. Each catheter has a cuff which is intended to be positioned underneath the skin at the skin exit to aid in securing the catheter and to provide a barrier to minimize the risk of infection. Each lumen is connected through an extension line with female Luer connectors. The transition between lumen and extension is housed within a molded hub. |
| Hemo-Flow Catheter | – | Device: Long term hemodialysis catheterThe Hemo-Flow® Catheter has two lumens (one arterial lumen, one venous lumen) comprised of a biocompatible polymeric material that contains radiopaque filler to allow radiographic imaging of the distal tips to ensure proper placement into the superior vena cava. The arterial lumen is utilized to withdraw blood from the patient and the venous lumen returns the blood to the patient after treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective patients (those who already have one of the Medcomp LTHD catheters inserted) will be enrolled. Retrospective patients from the previous 36 months will be approached for participation in the study. Patients who have previously received a Medcomp LTHD catheter will also be approached for consent and assessment of eligibility.
Key inclusion criteria (4 listed)
- ≥ 18 years of age at the time of enrollment
- Patients who have previously received the Medcomp subject device or patients currently receiving hemodialysis treatment, who have had a Medcomp subject device implanted for >90 days
- Health records relevant to this study are complete and accessible by Study team at the hemodialysis center, implantation center, medical facilities where complications are treated, and by the participating Principal Investigator (PI)
- Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form
Key exclusion criteria (2 listed)
- Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use
- Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Study in the opinion of the sponsor in consultation with the Principal Investigator)
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 |
|---|---|---|
| Long term hemodialysis catheterThere will be no interventions in this study. Strictly observational. | Device | Hemo-Flow Catheter, Titan HD Catheter |
Primary outcome
Insertion Success
Time frame: Percentage at Insertion
Successful initiation of vascular access device insertion, as determined by the investigator.
1 secondary outcome
Adverse Events (Infection per 1000 catheter days)
Time frame: 1000 catheter days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and ESRD, run by Medical Components, Inc dba MedComp at 2 sites in 2 countries.
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 2 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: withdrawn, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Insertion Success (time frame: Percentage at Insertion). 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 10 Jan 2024.