NCT02282449

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

October 30, 2014

Last Update Submit

October 24, 2016

Conditions

Malignancy

Keywords

Venous access devicePort cathetersChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence)

    Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence

    2 years after insertion

Secondary Outcomes (3)

  • Venous Thrombosis

    2 years after implantation

  • Quality of Life Related to Port

    2 years after implantation

  • Infection

    2 years after implantation

Study Arms (2)

Power Injectable Port

EXPERIMENTAL

The subjects randomized to this group will receive the newer, power injectable port.

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.

Device: Non-Power Injectable Port (Cook Vital Mini Port)

Interventions

Power Injectable Port (AngioDynamics Smart Port CT Mini)DEVICE

The subjects will all receive power injectable port.

Power Injectable Port
Non-Power Injectable Port (Cook Vital Mini Port)DEVICE

The subjects will all receive non-power injectable port.

Non-Power Injectable Port

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients breast cancer requiring intravenous chemotherapy, referred from our local Cancer Agency for arm TIVAD, will be included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Imaging, Royal University Hospital, 103 Hospital Drive

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (3)

  • 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.

    PMID: 21556721BACKGROUND

  • Marcy 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.

    PMID: 17981432BACKGROUND

  • Goltz 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.

    PMID: 21498324BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Brent E Burbridge, MD, FRCPC

    Medical Imaging, 103 Hospital Drive, Royal University Hospital, Saskatoon, SK, Canada S7N 0W8

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 4, 2014

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

CA(1)