NCT02887378

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

August 2, 2016

Last Update Submit

November 29, 2016

Conditions

Endoscopy

Keywords

bronchial biopsy

Outcome Measures

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).

    2 years

Study Arms (2)

hot clamps

EXPERIMENTAL

reusable hot biopsy forceps

Device: hot clamps

normal clamps

ACTIVE COMPARATOR

normal clamps

Device: normal clamps

Interventions

hot clampsDEVICE

reusable hot biopsy forceps

hot clamps
normal clampsDEVICE
normal clamps

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Amiens

Amiens, 80054, France

Location

Ch Saint Quentin

Saint-Quentin, 02321, France

Location

Study Officials

  • Youcef DOUADI, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

September 2, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

FR(2)