Merging of Endoscopic and Ultrasound Images for Laparosco... | NCT01705405

Studies
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

NCT01705405

Sponsor

AdministrateurCIC

Status

Terminated

Last Update Posted

Oct 18, 2016Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Software for acquiring ultrasound and endoscopic images

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

due to a problem of device

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Oct 5, 2012

First Submission Date that Met QC Criteria

Oct 11, 2012

First Posted Date

Oct 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2016

Last Update Posted Date

Oct 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

AdministrateurCIC, principal investigator, University Hospital, GrenobleSponsor-Investigator

Lead Sponsor

AdministrateurCICOTHER

Collaborators

Name	Class
TIMC-IMAG	OTHER
Clinical Investigation Centre for Innovative Technology Network	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
medical device	Experimental	medical device to acquire ultrasound and endoscopic images during surgery	Device: Software for acquiring ultrasound and endoscopic images

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Software for acquiring ultrasound and endoscopic images	Device	Use of a medical device to acquire ultrasound and endoscopic images	medical device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)		1year

Secondary Outcomes

Measure	Description	Time Frame
Percent of data(ultrasound and endoscopic) on which the merging works		1year
Percent of accurate merging	the merging is accurate if its error is under 5mm	1year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Alexandre Long, MD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology, University hospital of Grenoble		Grenoble	Isère	38000	France

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided