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CompletedNCT02887378PincesChaudeUpdated Nov 30, 2016

Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

An interventional study of hot clamps and normal clamps in Endoscopy, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-30.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Endoscopy

Keywords

  • bronchial biopsy
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    hot clamps

    reusable hot biopsy forceps

    Device: hot clamps

  • Active comparator
    normal clamps

    normal clamps

    Device: normal clamps

Interventions

  • Devicehot clamps

    reusable hot biopsy forceps

  • Devicenormal clamps
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 2 years

07

Study locations

2 sites
  • CHU Amiens
    Amiens, 80054, France
  • Ch Saint Quentin
    Saint Quentin, 02321, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02887378
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Sep 2, 2016
Start date
Sep 2014
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Nov 30, 2016

Study contacts

Youcef DOUADI, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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