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Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery


N/A
18 Years
90 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery


In order to help the surgeon to remove the prostate during a laparoscopic intervention, our
goal is to provide an innovative medical device that merges intra-operative ultrasound and
endoscopic images.

We have already achieved the proof of concept of a device that merges ultrasound and
endoscopic images. The objectives of this clinical trial are to accompany the maturation of
the fusion device and to make the initial assessments of its Medical Service.

The main difficulty is to visualize markers (surgical needles) under both modalities , in
order to merge them.


Inclusion Criteria:



- of-age patient

- patient for whom a radical prostatectomy is planned

- patient with a prostate volume between 30g and 100g

- patient affiliated to the social security or equivalent

- Written informed consent

Exclusion Criteria:

- contraindication

- patient who has undergone a significant prostate resection

- patient who has undergone a prostate irradiation

- patient concerned by the L1121-6 à 8 of the health public code

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)

Outcome Time Frame:

1year

Safety Issue:

No

Principal Investigator

Jean-Alexandre Long, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Grenoble

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

DCIC 12 06

NCT ID:

NCT01705405

Start Date:

October 2012

Completion Date:

September 2015

Related Keywords:

  • Prostate Cancer
  • cancer
  • prostate
  • Prostatic Neoplasms

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