NCT06531265

Brief Summary

This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 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

July 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

3.3 years

First QC Date

July 19, 2024

Last Update Submit

July 28, 2024

Conditions

Cryotherapy EffectBronchial Neoplasms

Keywords

cryobiopsycryotherapyendobronchial tumors

Outcome Measures

Primary Outcomes (2)

  • Diagnostic yield

    The recording of histopathological diagnosis as revealed by cryobiopsy

    within 10 days

  • Recanalization Success

    The measurement of degree of airway recanalization through bronchoscopic evaluation

    one day following the procedure

Secondary Outcomes (1)

  • Degree of dyspnea improvement after the procedure

    2 weeks after the procedure

Study Arms (1)

study group

EXPERIMENTAL

Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Procedure: Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy

Interventions

Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopyPROCEDURE

Bronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation

study group

Eligibility Criteria

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

You may qualify if:

  • patients with radiologically suspected endobronchial masses

You may not qualify if:

  • Patients with contraindications to bronchoscopy.
  • uncorrected coagulopathy (if the international normalized ratio (INR) is more than 1.5).
  • severe refractory hypoxemia (even after administering the highest possible dose of oxygen, the partial pressure of oxygen ("PaO2") stays below 70 mm Hg.
  • hypoventilation with hypercapnia (type 2 respiratory failure).
  • severe pulmonary hypertension \> 55 mmHg by echocardiography.
  • hemodynamic instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sohag University

Sohag, 82425, Egypt

Location

Sohag University

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Bronchial Neoplasms

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsBronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Sabah Ahmed, PHD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 31, 2024

Study Start

July 1, 2019

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)