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NCT02887378 Clinical Trial

Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

Endoscopy Clinical Trial

— PincesChaude  

Official title:
Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02887378
Other study ID # PI2014_843_0003
Secondary ID
Status Completed
Phase N/A
First received August 2, 2016
Last updated November 29, 2016
Start date September 2014
Est. completion date September 2016

Study information
Verified date November 2016
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• hot clamps
reusable hot biopsy forceps
• normal clamps

Locations
Country Name City State
France CHU Amiens Amiens
France Ch Saint Quentin Saint Quentin

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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