Protocol for Anatomopathologic Analysis of Biopsies Using... | NCT02887378

Studies
Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

NCT02887378

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Completed

Last Update Posted

Nov 30, 2016Estimated

Enrollment

46Actual

Phase

Not Applicable

Conditions

Endoscopy

Interventions

hot clamps
normal clamps

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 29, 2016

First Posted Date

Sep 2, 2016Estimated

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

Nov 29, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Description Module

Brief Summary

A cross-over study of the impact of histologic results of bronchial biopsies performed using hot clamps compared to bronchial biopsies using standard clamps

Detailed Description

Not provided

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hot clamps	Experimental	reusable hot biopsy forceps	Device: hot clamps
normal clamps	Active Comparator	normal clamps	Device: normal clamps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hot clamps	Device	reusable hot biopsy forceps	hot clamps
normal clamps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
use of reusable hot biopsy forceps	To show that the use of hot clamps (thermocoagulating) for endobronchial analysis does not affect the anatomopathologic interpretation of biopsies under certain conditions (with varying in intensity of current).	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years of age or older
Patients with no known hemorrhage risk, with an indication of endobronchial biopsy
Patients with no contra-indication for bronchial endoscopy
Patients with or without endobronchial tumors
Patients who have provided written informed consent
Patients with health insurance coverage

Exclusion Criteria:

Refusal to be examined
Contraindication for electrocoagulation (Pacemaker or metallic endobronchial prosthesis)
Pregnant women
Patients unable to provide voluntary informed consent, under (tutelage) or guardianship, or unable to come to the center

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Youcef DOUADI, PhD	CHU Amiens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens		Amiens		80054	France
Ch Saint Quentin