Cryotherapy EffectNCT06531265
Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors
A study testing Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy in people with Cryotherapy Effect and Bronchial Neoplasms, run by Sohag University at 2 sites in Egypt.
Trial summary
This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryotherapy Effect, Bronchial Neoplasms
- What is being tested?
- Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2019to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with radiologically suspected endobronchial masses
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors: A Prospective Study
This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors.
Read the detailed description
Novel flexible cryoprobes were introduced for tissue sampling during bronchoscopy. Employing this approach, the sample is collected when frozen, with the tissue attached to the frozen end of the probe. This approach enables the retrieval of larger tissue samples from endobronchial lesionsEndobronchial cryotherapy is employed to treat individuals with obstructive central bronchial lung cancers. It has been demonstrated to effectively recanalize obstructed respiratory passages, alleviate symptoms, and improve the quality of life for patients in advanced stagesThis study aimed to assess the effectiveness and safety of using bronchoscopic cryotechniques for diagnosing and treating endobronchial malignancies.
- Conditions
- Cryotherapy Effect, Bronchial Neoplasms
- Being tested
- Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy
- Keywords
- cryobiopsy, cryotherapy, endobronchial tumors
- Medical subject headings
- Bronchial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopyProcedure or surgery
Bronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy Receives: Procedure: Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The recording of histopathological diagnosis as revealed by cryobiopsy
Measured: within 10 days
Recanalization Success
The measurement of degree of airway recanalization through bronchoscopic evaluation
Measured: one day following the procedure
Secondary outcomes (1)
Degree of dyspnea improvement after the procedure
Measurement of degree of dyspnea before and after the procedure using Modified medical research counsil scale for dyspnea (mMRC scale)
Measured: 2 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jul 2019
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Hend Mohammed Abdelraheem Esmaeel, Sohag University
- Investigators
- Sabah Ahmed, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531265
- Sponsor's protocol ID
- Soh-Med-24-06--01PD
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors: A Prospective Study
- ClinicalTrials.gov ID
- NCT06531265
- Acronym / sponsor ID
- Soh-Med-24-06--01PD
- Conditions
- Cryotherapy Effect, Bronchial Neoplasms
- Keywords
- cryobiopsy, cryotherapy, endobronchial tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors.
Detailed description
Novel flexible cryoprobes were introduced for tissue sampling during bronchoscopy. Employing this approach, the sample is collected when frozen, with the tissue attached to the frozen end of the probe. This approach enables the retrieval of larger tissue samples from endobronchial lesionsEndobronchial cryotherapy is employed to treat individuals with obstructive central bronchial lung cancers. It has been demonstrated to effectively recanalize obstructed respiratory passages, alleviate symptoms, and improve the quality of life for patients in advanced stagesThis study aimed to assess the effectiveness and safety of using bronchoscopic cryotechniques for diagnosing and treating endobronchial malignancies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopyEndobronchial cryobiopsy and cryotherapy using flexible bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with radiologically suspected endobronchial masses
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopyBronchoscopic evaluation of endobronchial lesion with biopsy and cryotherapy for recanalisation | Procedure or surgery | study group |
Primary outcome
Diagnostic yield
Time frame: within 10 days
The recording of histopathological diagnosis as revealed by cryobiopsy
Recanalization Success
Time frame: one day following the procedure
The measurement of degree of airway recanalization through bronchoscopic evaluation
1 secondary outcome
Degree of dyspnea improvement after the procedure
Time frame: 2 weeks after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cryotherapy Effect
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabah Ahmed, PHD study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial cryobiopsy and cryotherapy using flexible bronchoscopy in people with Cryotherapy Effect and Bronchial Neoplasms, run by Sohag University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: within 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.