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Completed

NCT Number: NCT02132975

Motorised Probe Holder Assisting Prostate Biopsies

Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology, AP-HP Pitié Salpêtrière

Paris, Île-de-France Region, 75561, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • of-age patient
  • patient for whom a prostate biopsies session is planned
  • patient affiliated to the social security or equivalent
  • patient having a target identified on MRI
  • Written informed consent

Exclusion criteria

  • contraindication
  • patient wearing a mechatronic device
  • patient concerned by the L1121-6 à 8 of the health public code

Treatment and study plan

Biopsies using Apollo and UroStation®

Device

Apollo : Motorised probe handler for prostate biopsies

Biopsies using UroStation® (image fusion)

Procedure

Primary outcomes

  1. Distance between virtual and effective biopsy, in the two arms

    Time frame: 8 months

Secondary outcomes

  1. Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate

    Time frame: 8 months

  2. Probe holder positions error between virtual and effective biopsy

    Time frame: 8 months

  3. User satisfaction

    Time frame: 2 hours

    • biopsies session duration
    • device manageability
    • device unwiediness
    • contribution of the lock of the probe
    • set up, cleaning
    • global satisfaction

  4. Safety Evaluation

    Time frame: 2 hours

    • number of time the device couldn't be started
    • number of times the emergency button was pushed
    • number of time the biopsy couldn't entirely be done using the device
    • number of time the device protections had to be repositioned

Sponsors and collaborators

Lead sponsor

AdministrateurCIC

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network
  • Institute for Intelligent Systems and Robotics
  • Pitié-Salpêtrière Hospital

Registry information

Official study title

Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies

Acronym: PROSBOT-Apollo

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 7, 2014
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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