NeoplasmsPTCNCT07856745
Efficacy and Safety of FLEXIPORT Implantable Port in Chemotherapeutic Treatments
A study testing FLEXIPORT in people with Neoplasms, run by Portal Access Ltd. at 1 site in Dominican Republic.
Trial summary
The goal of this clinical trial is to assess, in a clinical setting, the efficacy and the safety of FLEXIPORT, a totally implantable venous access device (TIVAD) designed to provide a repeated access to the vascular system, in patients with malignant diseases requiring central venous access for administration of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- FLEXIPORT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDominican Republic
- Study dates
- 1 Apr 2024to 24 Feb 2026
- 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
- Age ≥18.
- Suffering from a malignancy and indicated for placement of a totally implantable vascular access device.
- Willing and able to return for the required follow-up visits following study enrollment.
- Signed informed consent.
Who cannot join
- Febrile illness within 7 days of study intervention.
- History of coagulopathy or ongoing anticoagulation therapy.
- Ongoing antibacterial treatment.
- History of bilateral axillary node dissection or bilateral upper thoracic irradiation.
- Known central venous stenosis.
- Life expectancy <3 months.
Show all 14Show fewer
- Requirement for high volume (apheresis) line.
- Cutaneous disease such as eczema, scleroderma, or infection at incision site(s).
- BMI >35 kg/m2.
- Known hypersensitivity to polyether ether ketone, silicone, titanium, aluminum, or vanadium.
- Known hypersensitivity to heparin or history of heparin-induced thrombocytopenia.
- Pregnancy or lactation.
- Prisoner.
- Employee of the Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm Study Evaluating the Efficacy and Safety of FLEXIPORT, a Single-incision Totally Implantable Venous Access Device, in Patients Receiving Chemotherapeutic Treatments
The goal of this clinical trial is to assess, in a clinical setting, the efficacy and the safety of FLEXIPORT, a totally implantable venous access device (TIVAD) designed to provide a repeated access to the vascular system, in patients with malignant diseases requiring central venous access for administration of chemotherapeutic treatments. The main question it aims to answer is what is the success rate of the device in providing vascular access, with the success rate defined as proportion of participants with a functioning device at 180 days post-implantation or at the time of removal, if the latter occurred for reasons other than adverse event or device deficiency.
- Conditions
- Neoplasms
- Being tested
- FLEXIPORT
- Keywords
- Vascular Access Devices, TIVAD
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEXIPORTDevice
Also called PorTal
FLEXIPORT is a totally implantable venous access device (TIVAD)
| Study group | Role | What they receive |
|---|---|---|
| FLEXIPORT | Experimental | If the eligibility criteria are fulfilled, FLEXIPORT will be implanted in either a dual-incision (access and port incisions) or a single-incision (access incision only) procedure. Receives: Device: FLEXIPORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Proportion of participants with a functioning device at 180 days post-implantation or at the time of removal, if the latter occurred for reasons other than adverse event or device deficiency.
Measured: within 6-8 months post-implantation
Secondary outcomes (6)
Intra-operative adverse event rate
Rate of adverse events related to the device or the procedure occurring at the time of implantation
Measured: Periprocedural
Post-operative adverse event rate
Rate of adverse events related to the device or the procedure occurring after the implantation
Measured: within 6-8 months post-implantation
Rate of device-related bloodstream infections
Rate of bloodstream infections, with a pathogen grown and recognized in blood culture, occurring with the device in place for ≥48 hours.
Measured: from 48 hours to 6-8 months post-implantation
Rate of access site infections
Rate of events at the access site that require antibiotic therapy and delay line use
Measured: within 6-8 months post-implantation
Rate of tunnel infections
Rate of events at the tunnel site that require antibiotic therapy and delay line use
Measured: within 6-8 months post-implantation
Rate of port site infection
Rate of events at the port site that require antibiotic therapy and delay line use
Measured: within 6-8 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Apr 2024
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portal Access Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856745
- Sponsor's protocol ID
- CL-005
- Acronym
- PTC
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Study Evaluating the Efficacy and Safety of FLEXIPORT, a Single-incision Totally Implantable Venous Access Device, in Patients Receiving Chemotherapeutic Treatments
- ClinicalTrials.gov ID
- NCT07856745
- Acronym / sponsor ID
- PTC / CL-005
- Conditions
- Neoplasms
- Keywords
- Vascular Access Devices, TIVAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Portal Access Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 5 Oct 2026 (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 goal of this clinical trial is to assess, in a clinical setting, the efficacy and the safety of FLEXIPORT, a totally implantable venous access device (TIVAD) designed to provide a repeated access to the vascular system, in patients with malignant diseases requiring central venous access for administration of chemotherapeutic treatments. The main question it aims to answer is what is the success rate of the device in providing vascular access, with the success rate defined as proportion of participants with a functioning device at 180 days post-implantation or at the time of removal, if the latter occurred for reasons other than adverse event or device deficiency.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLEXIPORT | Experimental | Device: FLEXIPORTIf the eligibility criteria are fulfilled, FLEXIPORT will be implanted in either a dual-incision (access and port incisions) or a single-incision (access incision only) procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18.
- Suffering from a malignancy and indicated for placement of a totally implantable vascular access device.
- Willing and able to return for the required follow-up visits following study enrollment.
- Signed informed consent.
Key exclusion criteria (14 listed)
- Febrile illness within 7 days of study intervention.
- History of coagulopathy or ongoing anticoagulation therapy.
- Ongoing antibacterial treatment.
- History of bilateral axillary node dissection or bilateral upper thoracic irradiation.
- Known central venous stenosis.
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 |
|---|---|---|
| FLEXIPORTAlso: PorTalFLEXIPORT is a totally implantable venous access device (TIVAD) | Device | FLEXIPORT |
Primary outcome
Success rate
Time frame: within 6-8 months post-implantation
Proportion of participants with a functioning device at 180 days post-implantation or at the time of removal, if the latter occurred for reasons other than adverse event or device deficiency.
6 secondary outcomes
Intra-operative adverse event rate
Time frame: Periprocedural
Post-operative adverse event rate
Time frame: within 6-8 months post-implantation
Rate of device-related bloodstream infections
Time frame: from 48 hours to 6-8 months post-implantation
Rate of access site infections
Time frame: within 6-8 months post-implantation
Rate of tunnel infections
Time frame: within 6-8 months post-implantation
Rate of port site infection
Time frame: within 6-8 months post-implantation
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 5 Oct 2026.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEXIPORT in people with Neoplasms, run by Portal Access Ltd. at 1 site in Dominican Republic.
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 14 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 5 Oct 2026. 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 Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: within 6-8 months post-implantation). 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 5 Oct 2026.