Study Stopped
study never start
Exploration of the Pleural Cavity Using a fleXible endoscoPe
EXPLORE
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 17, 2016
August 1, 2016
5 months
April 30, 2015
August 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completeness of the pleural cavity exploration using the flexible endoscope
Two independent experts will visualize the video-recordings of the intervention and evaluate the completeness of the exploration using a standardized score.
at 0 hours
Secondary Outcomes (8)
Outcome of a complication
at 0 hours
Outcome of a complication
at 4 hours
Outcome of a complication
Day 7
Outcome of a complication
1 month
Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention
Day -7 : 7 days before the intervention
- +3 more secondary outcomes
Study Arms (1)
Thoracoscopy
EXPERIMENTAL1. experimental intervention (flexible video endoscope) 2. reference procedure (video-rigid thoracoscope)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of pleural effusion affirmed by chest radiography,
- Indication thoracoscopy, asked by the pulmonologist or thoracic surgeon for diagnostic investigation and / or pleural symphysis
- Inpatient or outpatient,
- Women of childbearing age having an effective contraceptive coverage (combined oral contraceptives or intrauterine device or tubal ligation); a negative pregnancy test should be obtained,
- For postmenopausal women, menopause confirmation of diagnosis,
You may not qualify if:
- Pleural effusion compression,
- Pleural effusion infected or suspected of infection,
- Febrile patient (\> 38 ° C)
- Parapneumonic effusion
- Immunosuppression (eg, neutropenia \<1G / L, immunosuppressive therapy, ...)
- Portage known multidrug-resistant germ or S. aureus resistant to methicillin,
- Clinical suspicion of tuberculosis,
- Patients who have already been treated by pleurodesis,
- Contraindication to general anesthesia,
- Contraindication of prophylactic antibiotics,
- Contraindication to pleurodesis agent
- Increased bleeding risk,
- No one deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)
- Pregnant or breastfeeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BASTE Jean Marc, MD
University Hospital, Rouen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
June 4, 2015
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
August 17, 2016
Record last verified: 2016-08