MalignancyNCT02282449
Power Injectable Versus a Non-Power Injectable, Upper Arm, TIVAD for Chemotherapy
A study testing Power Injectable Port (AngioDynamics Smart Port CT Mini) and Non-Power Injectable Port (Cook Vital Mini Port) in people with Malignancy, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Patients with cancer often require intravenous chemotherapy for long periods of time. Ensuring that these patients have safe and reliable access to the veins for chemotherapy is challenging, and sometimes a medical device is required to administer the chemotherapy into the veins. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Malignancy
- What is being tested?
- Power Injectable Port (AngioDynamics Smart Port CT Mini) and Non-Power Injectable Port (Cook Vital Mini Port)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jul 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive patients breast cancer requiring intravenous chemotherapy, referred from our local Cancer Agency for arm TIVAD, will be included.
Who cannot join
- • Those under the age of 16 years;
- Those with uncorrectable blood clotting disorder;
- Pregnant women, as they will not be candidates for chemotherapy;
- Any person with an active infection or immunocompromised state;
- Those on oral or intravenous antibiotics on the day of TIVAD implantation.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Medical Imaging, Royal University Hospital, 103 Hospital Drive
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Assessment of a Power Injectable vs. a Non-Power Injectable, Upper Arm, Totally Implanted Venous Access Devices for Chemotherapy
Patients with cancer often require intravenous chemotherapy for long periods of time.
Ensuring that these patients have safe and reliable access to the veins for chemotherapy is challenging, and sometimes a medical device is required to administer the chemotherapy into the veins.
Read more
A totally implanted venous access device, or port, is implanted under the skin of the arm and is attached to a small plastic catheter that enters into the veins. This device can be punctured with a needle when needed for treatment or testing.
Some types of these vein ports can rapidly inject fluids (power injection), and can be used for follow-up imaging studies, such as computed tomography, that are required to follow cancer treatment effectiveness. There are no publications of randomized patients discussing the impact of power injection upon TIVAD complications and device longevity for arm implantation. The investigators propose to compare the effectiveness of power injectable against non-power injectable ports to determine if they have different clinical performance and complications. Our results will impact the care provided to cancer patients.
Read the detailed description
Hypothesis:
The null hypothesis envisions both devices performing similarly in regards to chemotherapy and complications. However, the power injectable population will experience the high flow, large volume injections, may experience complications of injection extravasation and port damage due to the more vigorous injection parameters.
Trial Objectives:
- To prospectively assess the functionality and complications of a power injectable vs. a non-power injectable TIVAD in a cohort of breast cancer patients requiring intravenous chemotherapy. The TIVAD will be randomly assigned to each patient.
- Assess quality of life for subjects who have the two different TIVADs.
- Facilitate device selection for future cancer patients requiring chemotherapy.
We will perform a randomized, prospective clinical trial of patients with cancer to compare a non-power injectable port, Cook Vital Mini Port (Cook Canada, Mississauga, ON), with a power injectable port, the AngioDynamics Smart Port CT Mini (AngioDynamics Inc., Manchester, GA, USA).
Adverse events, such as arm swelling, skin rash, and incision dehiscence, etc., will be tracked via an online reporting system, a patient registry, and by follow-up strategies related to imaging and clinical assessments at regular time intervals.
Patient Follow-up:
From the Insertion date, a 7 day post insertion telephone interview will be performed. Subsequently the following will be obtained at 3 months and 12 months post port insertion.
Clinical examination Venous Doppler US (arm/neck) Chest and arm X-ray QLQC30 questionnaire QLAVD-PA questionnaire Adverse Event Record
Details of Follow-up:
Clinical Examination:
Visual inspection of the arm, port implantation site, neck, and anterior chest.
- Distended arm, neck or chest veins - Y/N - details
- Swollen or edematous arm, neck, chest - Y/N - details
- Skin rash - Y/N - details
- Signs of arm infection - redness, swelling, purulent discharge - Y/N - details
- Abnormal incision site of port insertion - Y/N - details
Venous Doppler Ultrasound (arm/neck):
Ultrasound will assess for vein thrombosis or narrowing.
Chest and arm x-rays:
Standard x-rays to include the arm from at least the elbow to axilla, full chest x-ray.
QLCC30 and QLAVD-PA:
Quality of Life surveys.
Adverse Events:
7 days, 3 months, 12 months, up to 24 months if possible - The patient will be contacted by telephone to determine if they have experienced any adverse events.
- Conditions
- Malignancy
- Being tested
- Power Injectable Port (AngioDynamics Smart Port CT Mini), Non-Power Injectable Port (Cook Vital Mini Port)
- Keywords
- Venous access device, Port catheters, Chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Injectable Port (AngioDynamics Smart Port CT Mini)Device
The subjects will all receive power injectable port.
Non-Power Injectable Port (Cook Vital Mini Port)Device
The subjects will all receive non-power injectable port.
| Study group | Role | What they receive |
|---|---|---|
| Power Injectable Port | Experimental | The subjects randomized to this group will receive the newer, power injectable port. Receives: Device: Power Injectable Port (AngioDynamics Smart Port CT Mini) |
| Non-Power Injectable Port | Active comparator | The subjects randomized to this group will receive the older, non-power injectable port. Receives: Device: Non-Power Injectable Port (Cook Vital Mini Port) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence)
Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence
Measured: 2 years after insertion
Secondary outcomes (3)
Venous Thrombosis
Ipsilateral US of veins of arm and neck to detect venous thrombosis
Measured: 2 years after implantation
Quality of Life Related to Port
Surveys of quality of life will be performed for each device
Measured: 2 years after implantation
Infection
Detect implantation site or systemic infection related to the port.
Measured: 2 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalignancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Burbridge, University of Saskatchewan
- Investigators
- Brent E Burbridge, MD, FRCPC, Principal investigator, Medical Imaging, 103 Hospital Drive, Royal University Hospital, Saskatoon, SK, Canada S7N 0W8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282449
- Sponsor's protocol ID
- 13-42
- Status last verified
- Oct 2016
- First submitted
- 30 Oct 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goossens GA, Stas M, Jerome M, Moons P. Systematic review: malfunction of totally implantable venous access devices in cancer patients. Support Care Cancer. 2011 Jul;19(7):883-98. doi: 10.1007/s00520-011-1171-3. Epub 2011 May 10.
PubMed 21556721Marcy PY, Chamorey E, Amoretti N, Benezery K, Bensadoun RJ, Bozec A, Poissonnet G, Dassonville O, Rame M, Italiano A, Peyrade F, Brenac F, Gallard JC. A comparison between distal and proximal port device insertion in head and neck cancer. Eur J Surg Oncol. 2008 Nov;34(11):1262-9. doi: 10.1016/j.ejso.2007.09.011. Epub 2007 Nov 5.
PubMed 17981432Goltz JP, Machann W, Noack C, Hahn D, Kickuth R. Feasibility of power contrast injections and bolus triggering during CT scans in oncologic patients with totally implantable venous access ports of the forearm. Acta Radiol. 2011 Feb 1;52(1):41-7. doi: 10.1258/ar.2010.100238.
PubMed 21498324
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Power Injectable vs. a Non-Power Injectable, Upper Arm, Totally Implanted Venous Access Devices for Chemotherapy
- ClinicalTrials.gov ID
- NCT02282449
- Acronym / sponsor ID
- 13-42
- Conditions
- Malignancy
- Keywords
- Venous access device, Port catheters, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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.
Patients with cancer often require intravenous chemotherapy for long periods of time.
Ensuring that these patients have safe and reliable access to the veins for chemotherapy is challenging, and sometimes a medical device is required to administer the chemotherapy into the veins.
A totally implanted venous access device, or port, is implanted under the skin of the arm and is attached to a small plastic catheter that enters into the veins. This device can be punctured with a needle when needed for treatment or testing.
Some types of these vein ports can rapidly inject fluids (power injection), and can be used for follow-up imaging studies, such as computed tomography, that are required to follow cancer treatment effectiveness. There are no publications of randomized patients discussing the impact of power injection upon TIVAD complications and device longevity for arm implantation. The investigators propose to compare the effectiveness of power injectable against non-power injectable ports to determine if they have different clinical performance and complications. Our results will impact the care provided to cancer patients.
Detailed description
Hypothesis:
The null hypothesis envisions both devices performing similarly in regards to chemotherapy and complications. However, the power injectable population will experience the high flow, large volume injections, may experience complications of injection extravasation and port damage due to the more vigorous injection parameters.
Trial Objectives:
- To prospectively assess the functionality and complications of a power injectable vs. a non-power injectable TIVAD in a cohort of breast cancer patients requiring intravenous chemotherapy. The TIVAD will be randomly assigned to each patient.
- Assess quality of life for subjects who have the two different TIVADs.
- Facilitate device selection for future cancer patients requiring chemotherapy.
We will perform a randomized, prospective clinical trial of patients with cancer to compare a non-power injectable port, Cook Vital Mini Port (Cook Canada, Mississauga, ON), with a power injectable port, the AngioDynamics Smart Port CT Mini (AngioDynamics Inc., Manchester, GA, USA).
Adverse events, such as arm swelling, skin rash, and incision dehiscence, etc., will be tracked via an online reporting system, a patient registry, and by follow-up strategies related to imaging and clinical assessments at regular time intervals.
Patient Follow-up:
From the Insertion date, a 7 day post insertion telephone interview will be performed. Subsequently the following will be obtained at 3 months and 12 months post port insertion.
Clinical examination Venous Doppler US (arm/neck) Chest and arm X-ray QLQC30 questionnaire QLAVD-PA questionnaire Adverse Event Record
Details of Follow-up:
Clinical Examination:
Visual inspection of the arm, port implantation site, neck, and anterior chest.
- Distended arm, neck or chest veins - Y/N - details
- Swollen or edematous arm, neck, chest - Y/N - details
- Skin rash - Y/N - details
- Signs of arm infection - redness, swelling, purulent discharge - Y/N - details
- Abnormal incision site of port insertion - Y/N - details
Venous Doppler Ultrasound (arm/neck):
Ultrasound will assess for vein thrombosis or narrowing.
Chest and arm x-rays:
Standard x-rays to include the arm from at least the elbow to axilla, full chest x-ray.
QLCC30 and QLAVD-PA:
Quality of Life surveys.
Adverse Events:
7 days, 3 months, 12 months, up to 24 months if possible - The patient will be contacted by telephone to determine if they have experienced any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power Injectable Port | Experimental | Device: Power Injectable Port (AngioDynamics Smart Port CT Mini)The subjects randomized to this group will receive the newer, power injectable port. |
| Non-Power Injectable Port | Active comparator | Device: Non-Power Injectable Port (Cook Vital Mini Port)The subjects randomized to this group will receive the older, non-power injectable port. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients breast cancer requiring intravenous chemotherapy, referred from our local Cancer Agency for arm TIVAD, will be included.
Key exclusion criteria (5 listed)
- • Those under the age of 16 years;
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 |
|---|---|---|
| Power Injectable Port (AngioDynamics Smart Port CT Mini)The subjects will all receive power injectable port. | Device | Power Injectable Port |
| Non-Power Injectable Port (Cook Vital Mini Port)The subjects will all receive non-power injectable port. | Device | Non-Power Injectable Port |
Primary outcome
Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence)
Time frame: 2 years after insertion
Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence
3 secondary outcomes
Venous Thrombosis
Time frame: 2 years after implantation
Quality of Life Related to Port
Time frame: 2 years after implantation
Infection
Time frame: 2 years after 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 26 Oct 2016.
- Background: PubMed 21556721Goossens GA, Stas M, Jerome M, Moons P. Systematic review: malfunction of totally implantable venous access devices in cancer patients. Support Care Cancer. 2011 Jul;19(7):883-98. doi: 10.1007/s00520-011-1171-3. Epub 2011 May 10.
- Background: PubMed 17981432Marcy PY, Chamorey E, Amoretti N, Benezery K, Bensadoun RJ, Bozec A, Poissonnet G, Dassonville O, Rame M, Italiano A, Peyrade F, Brenac F, Gallard JC. A comparison between distal and proximal port device insertion in head and neck cancer. Eur J Surg Oncol. 2008 Nov;34(11):1262-9. doi: 10.1016/j.ejso.2007.09.011. Epub 2007 Nov 5.
- Background: PubMed 21498324Goltz JP, Machann W, Noack C, Hahn D, Kickuth R. Feasibility of power contrast injections and bolus triggering during CT scans in oncologic patients with totally implantable venous access ports of the forearm. Acta Radiol. 2011 Feb 1;52(1):41-7. doi: 10.1258/ar.2010.100238.
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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.
Brent E Burbridge, MD, FRCPC principal investigator
Medical Imaging, 103 Hospital Drive, Royal University Hospital, Saskatoon, SK, Canada S7N 0W8
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Injectable Port (AngioDynamics Smart Port CT Mini) and Non-Power Injectable Port (Cook Vital Mini Port) in people with Malignancy, run by University of Saskatchewan at 1 site in Canada.
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 1 inclusion and 5 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 26 Oct 2016. 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 Canada. 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?
Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence) (time frame: 2 years after insertion). 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 NCT02282449, which also lists 3 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 26 Oct 2016.