Navigation Guidance Gestures Carried Out Under CT

Biopsy Clinical Trial

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Official title:

Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828893
• Other study ID #: DCIC 08 01
• Secondary ID: IMACTIS company
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 23, 2009
• Last updated: February 17, 2012
• Start date: October 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• more or equal than 18 years old

• patient affiliated to social security or similarly regime

• patient sent to hospital for drain under CT

Exclusion Criteria:

• Pregnant women and lactating mothers

• Ward of court or under guardianship

• Adult unable to express their consent

• Person deprived of freedom by judicial or administrative decision

• Person hospitalized without their consent

• Person under legal protection

• Person participating in another clinical study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biopsy
• Drainage
• Punction

Intervention

Device:
• navigation station
navigation station for gestures (carried out under CT) guidance

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
AdministrateurCIC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.		2 hours	Yes
Secondary	Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.		2 hours	Yes
Secondary	Duration of intervention		3 hours	Yes
Secondary	Dose irradiation and number of control scanners made		3 hours	Yes
Secondary	overall satisfaction Score		3 hours	Yes
Secondary	Success or failure of the final gesture made		3 hours	Yes
Secondary	Number of attempts		3 hours	Yes
Secondary	number of complications (per-operative, post-surgery)		7 days	Yes

External Links

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