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Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

NCT ID: NCT02887378

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Endoscopy

Keywords

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bronchial biopsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hot clamps

reusable hot biopsy forceps

Group Type EXPERIMENTAL

hot clamps

Intervention Type DEVICE

reusable hot biopsy forceps

normal clamps

normal clamps

Group Type ACTIVE_COMPARATOR

normal clamps

Intervention Type DEVICE

Interventions

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hot clamps

reusable hot biopsy forceps

Intervention Type DEVICE

normal clamps

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Youcef DOUADI, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Ch Saint Quentin

Saint-Quentin, , France

Site Status

Countries

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France

Other Identifiers

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PI2014_843_0003

Identifier Type: -

Identifier Source: org_study_id