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BONE ANCHORED PORT for Hemodialysis Treatment

NCT02069860 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-11-21

No results posted yet for this study

Summary

A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear, connected with a double lumen central venous catheter inserted in the jugular vein, and will be used in conjunction with an adapter as a permanent vascular access for hemodialysis treatment.

Conditions

  • End-Stage Renal Disease Requiring Haemodialysis
  • Hemodialysis Access Failure (Disorder)

Interventions

DEVICE

Bone Anchored Port System (BAP)

The port body will be implanted onto the petrous bone and a sealing cap, a twofold valve system and a catheter are connected to the port body. The catheter is tunneled under the skin, enters the internal jugular vein and ends in the right atrium of the heart. The novelty of the access lies in its location (retro auricular on petrous bone) and its bone fixation.

Sponsors & Collaborators

  • Cendres+Métaux

    lead INDUSTRY

Principal Investigators

  • Uehlinger Dominik, Prof. Dr. med. · University Hospital, Inselspital, Berne, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-04
Primary Completion
2019-12-23
Completion
2022-07-12

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02069860 on ClinicalTrials.gov