Vascular Access DeviceNCT07549035
Radiographic External Measurement Technique for TIVAP Placement
A study testing Chest X-Ray-Based External Measurement Method in people with Vascular Access Device and Catherization, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Totally implantable venous access ports (TIVAPs) are commonly used in patients who need long-term intravenous treatment such as chemotherapy, parenteral nutrition, or repeated blood sampling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Device, Catherization
- What is being tested?
- Chest X-Ray-Based External Measurement Method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2026to 27 May 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 years or older
- Scheduled for elective totally implantable venous access port placement
- Available posterior-anterior chest X-ray obtained within the previous 3 months
- Ability to provide written informed consent
Who cannot join
- Known central venous stenosis or occlusion due to previous central venous catheter or port history
- Congenital heart disease
- Significant mediastinal anatomical abnormality or distortion
- Chest X-ray in which anatomical landmarks cannot be clearly identified
- Emergency port implantation
- Pregnancy (if required by local ethics policy)
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Bagcilar Education and Training Hospital
Istanbul, ABD Dışında, 34400
About this study
Official title: Accuracy and Clinical Applicability of a Chest X-Ray-Based External Measurement Method for Optimal Catheter Tip Positioning in Totally Implantable Venous Access Port Placement
Totally implantable venous access ports (TIVAPs) are commonly used in patients who need long-term intravenous treatment such as chemotherapy, parenteral nutrition, or repeated blood sampling. Correct placement of the catheter tip is important to reduce the risk of complications, including arrhythmia, thrombosis, catheter dysfunction, vessel injury, and infection.
Several methods are used to determine catheter tip position during port placement, including fluoroscopy, echocardiography, and chest X-ray. However, some of these methods may require additional equipment, increase procedure time, or may not be available in all hospitals.
Read more
This study aims to evaluate a simple chest X-ray-based external measurement method to estimate the appropriate catheter length before TIVAP placement. In this method, anatomical landmarks identified on a recent chest X-ray are used to calculate the expected catheter length, which is then applied during the procedure.
The main goal of the study is to assess how accurately this method places the catheter tip in the desired anatomical position. Secondary goals include evaluating the rate of optimal tip placement, procedure-related complications, and the relationship between predicted and actual catheter tip positions.
If successful, this method may provide a practical, low-cost, and widely applicable technique to improve TIVAP placement in routine clinical practice.
- Conditions
- Vascular Access Device, Catherization
- Being tested
- Chest X-Ray-Based External Measurement Method
- Keywords
- Totally Implantable Venous Access Port, Port Catheter, Central Venous Catheter Catheter Tip Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest X-Ray-Based External Measurement MethodProcedure or surgery
A pre-procedural measurement technique used during totally implantable venous access port placement. Anatomical landmarks identified on a recent posterior-anterior chest X-ray are used to estimate the appropriate catheter length before implantation in order to optimize final catheter tip position.
| Study group | Role | What they receive |
|---|---|---|
| Chest X-Ray-Based External Measurement Group | Experimental | Participants in this arm undergo totally implantable venous access port placement using a chest X-ray-based external measurement method to determine catheter length before implantation. Anatomical landmarks identified on a recent chest X-ray are used to estimate the target catheter length. Post-procedure chest X-ray is performed to assess final catheter tip position and procedural outcomes. Receives: Procedure: Chest X-Ray-Based External Measurement Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Optimal Catheter Tip Positioning
Proportion of participants with the catheter tip located at the cavoatrial junction or within 1-2 cm proximal to this level on post-procedure chest X-ray.
Measured: Immediately after port implantation (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start6 Mar 2026
- Primary completion26 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access DeviceStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-group study in which all enrolled participants undergo totally implantable venous access port placement using a chest X-ray-based external measurement method for catheter length determination. Post-procedure chest X-ray is used to evaluate catheter tip position and procedural outcomes.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasim Onur Karaoglu, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549035
- Sponsor's protocol ID
- 6814288
- Status last verified
- May 2026
- First submitted
- 18 Apr 2026
- Last updated
- 29 May 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Clinical Applicability of a Chest X-Ray-Based External Measurement Method for Optimal Catheter Tip Positioning in Totally Implantable Venous Access Port Placement
- ClinicalTrials.gov ID
- NCT07549035
- Acronym / sponsor ID
- 6814288
- Conditions
- Vascular Access Device, Catherization
- Keywords
- Totally Implantable Venous Access Port, Port Catheter, Central Venous Catheter Catheter Tip Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 23 Apr 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.
Totally implantable venous access ports (TIVAPs) are commonly used in patients who need long-term intravenous treatment such as chemotherapy, parenteral nutrition, or repeated blood sampling. Correct placement of the catheter tip is important to reduce the risk of complications, including arrhythmia, thrombosis, catheter dysfunction, vessel injury, and infection.
Several methods are used to determine catheter tip position during port placement, including fluoroscopy, echocardiography, and chest X-ray. However, some of these methods may require additional equipment, increase procedure time, or may not be available in all hospitals.
This study aims to evaluate a simple chest X-ray-based external measurement method to estimate the appropriate catheter length before TIVAP placement. In this method, anatomical landmarks identified on a recent chest X-ray are used to calculate the expected catheter length, which is then applied during the procedure.
The main goal of the study is to assess how accurately this method places the catheter tip in the desired anatomical position. Secondary goals include evaluating the rate of optimal tip placement, procedure-related complications, and the relationship between predicted and actual catheter tip positions.
If successful, this method may provide a practical, low-cost, and widely applicable technique to improve TIVAP placement in routine clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-group study in which all enrolled participants undergo totally implantable venous access port placement using a chest X-ray-based external measurement method for catheter length determination. Post-procedure chest X-ray is used to evaluate catheter tip position and procedural outcomes.
| Arm | Type | Receives |
|---|---|---|
| Chest X-Ray-Based External Measurement Group | Experimental | Procedure: Chest X-Ray-Based External Measurement MethodParticipants in this arm undergo totally implantable venous access port placement using a chest X-ray-based external measurement method to determine catheter length before implantation. Anatomical landmarks identified on a recent chest X-ray are used to estimate the target catheter length. Post-procedure chest X-ray is performed to assess final catheter tip position and procedural outcomes. |
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 years or older
- Scheduled for elective totally implantable venous access port placement
- Available posterior-anterior chest X-ray obtained within the previous 3 months
- Ability to provide written informed consent
Key exclusion criteria (7 listed)
- Known central venous stenosis or occlusion due to previous central venous catheter or port history
- Congenital heart disease
- Significant mediastinal anatomical abnormality or distortion
- Chest X-ray in which anatomical landmarks cannot be clearly identified
- Emergency port implantation
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 |
|---|---|---|
| Chest X-Ray-Based External Measurement MethodA pre-procedural measurement technique used during totally implantable venous access port placement. Anatomical landmarks identified on a recent posterior-anterior chest X-ray are used to estimate the appropriate catheter length before implantation in order to optimize final catheter tip position. | Procedure or surgery | Chest X-Ray-Based External Measurement Group |
Primary outcome
Accuracy of Optimal Catheter Tip Positioning
Time frame: Immediately after port implantation (within 24 hours)
Proportion of participants with the catheter tip located at the cavoatrial junction or within 1-2 cm proximal to this level on post-procedure chest X-ray.
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 29 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest X-Ray-Based External Measurement Method in people with Vascular Access Device and Catherization, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 29 May 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 Turkey (Türkiye). 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?
Accuracy of Optimal Catheter Tip Positioning (time frame: Immediately after port implantation (within 24 hours)). 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 29 May 2026.