Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps (PincesChaude)

November 29, 2016 updated by: Centre Hospitalier Universitaire, Amiens
A cross-over study of the impact of histologic results of bronchial biopsies performed using hot clamps compared to bronchial biopsies using standard clamps

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Saint Quentin, France, 02321
        • CH Saint Quentin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hot clamps
reusable hot biopsy forceps
Device: hot clamps
reusable hot biopsy forceps
Active Comparator: normal clamps
Device: normal clamps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
use of reusable hot biopsy forceps
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Youcef DOUADI, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2014_843_0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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