NCT01733342

Brief Summary

To compare the performance of domestic chemoport and imported chemoport

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for phase_4 cancer

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4 cancer

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

November 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

November 13, 2012

Last Update Submit

December 2, 2013

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • function of chemoport

    Whether or not chemoport function is intact will be assessed. Chemoport function will be rendered as intact when chemotherapeutic agent is well infused through the chemoport. Chemoport function will be rendered as not intact when chemotherapeutic agent could be infused through the chemoport.

    6 months

Secondary Outcomes (4)

  • infection

    6 months

  • Skin dehiscence

    6 months

  • deep vein thrombosis

    6 months

  • Fibrin sheath

    6 months

Study Arms (2)

Celsite

ACTIVE COMPARATOR

patients received celsite chemoport implantation under local anesthesia

Device: Celsite chemoport implantationProcedure: local anesthesia

Humanport

EXPERIMENTAL

patients received Humanport chemoport implantation under local anesthesia

Procedure: local anesthesiaDevice: Humanport chemoport implantation

Interventions

Celsite chemoport implantationDEVICE

Celsite chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance

Celsite
local anesthesiaPROCEDURE

chemoport implantation will be done under local anesthesia using lidocaine.

CelsiteHumanport
Humanport chemoport implantationDEVICE

Humanport chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance

Humanport

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who will receive chemotherapy via implantable port
  • age \>20 years
  • expected life time \> 6 months
  • lab test (platelet\>50K, PT INR \<2.0)

You may not qualify if:

  • performance status \>2
  • brain metastasis
  • expected life time less than 6 months
  • age less than 20 years
  • active infection
  • severe heart dysfunction
  • recent myocardial infarct

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (5)

  • Niederhuber JE, Ensminger W, Gyves JW, Liepman M, Doan K, Cozzi E. Totally implanted venous and arterial access system to replace external catheters in cancer treatment. Surgery. 1982 Oct;92(4):706-12.

    PMID: 7123491BACKGROUND

  • Ahn SJ, Kim HC, Chung JW, An SB, Yin YH, Jae HJ, Park JH. Ultrasound and fluoroscopy-guided placement of central venous ports via internal jugular vein: retrospective analysis of 1254 port implantations at a single center. Korean J Radiol. 2012 May-Jun;13(3):314-23. doi: 10.3348/kjr.2012.13.3.314. Epub 2012 Apr 17.

    PMID: 22563269BACKGROUND

  • Teichgraber UK, Kausche S, Nagel SN, Gebauer B. Outcome analysis in 3,160 implantations of radiologically guided placements of totally implantable central venous port systems. Eur Radiol. 2011 Jun;21(6):1224-32. doi: 10.1007/s00330-010-2045-7. Epub 2011 Jan 5.

    PMID: 21207035BACKGROUND

  • Teichgraber UK, Kausche S, Nagel SN. Evaluation of radiologically implanted central venous port systems explanted due to complications. J Vasc Access. 2011 Oct-Dec;12(4):306-12. doi: 10.5301/JVA.2011.7739.

    PMID: 21534232BACKGROUND

  • Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nole F, Andreoni B. Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days. Ann Oncol. 1998 Jul;9(7):767-73. doi: 10.1023/a:1008392423469.

    PMID: 9739444BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Hyo-Cheol Kim, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 27, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

KR(1)