NCT01705405

Brief Summary

Visualize surgical needles inserted in the prostate, under the ultrasound modality.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

October 5, 2012

Last Update Submit

October 17, 2016

Conditions

Prostate Cancer

Keywords

cancerprostate

Outcome Measures

Primary Outcomes (1)

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

    1year

Secondary Outcomes (3)

  • Percent of data(ultrasound and endoscopic) on which the merging works

    1year

  • Percent of accurate merging

    1year

  • Percent of mistaken segmentation of the vesical neck in the endoscopic image

    1year

Study Arms (1)

medical device

EXPERIMENTAL

medical device to acquire ultrasound and endoscopic images during surgery

Device: Software for acquiring ultrasound and endoscopic images

Interventions

Software for acquiring ultrasound and endoscopic imagesDEVICE

Use of a medical device to acquire ultrasound and endoscopic images

medical device

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology, University hospital of Grenoble

Grenoble, Isère, 38000, France

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jean-Alexandre Long, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 12, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

FR(1)