Laryngeal DiseaseNCT04231344
Laryngeal Disorders and GERD in Assiut University
An observational study of Laryngeal Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Study laryngeal disorders by laryngoscopic examination by two physicians on GERD patients diagnosed by gastroenterology department by endoscopy and effect of GERD treatment for 3 months on these laryngeal disorders without any treatment to laryngeal disorders Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Disease
- What is being tested?
- Laryngoscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Feb 2022
- Phase
- Observational
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who diagnosed GERD by gastroenterology department before start of treatment of GERD Will examine by laryngoscopy for laryngeal lesions then they Will take treatment to GERD by gastroenterology department without any treatment to laryngeal disorders and study effect of GERD treatment on these laryngeal disorders
Who may be able to join
- Patients diagnosed GERD by gastroenterology department before start of treatment and have laryngeal symptoms
Who cannot join
- voice abusers as singers ,teachers and readers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Laryngeal Disorders in Patients With GERD in Assiut University Hospital
Study laryngeal disorders by laryngoscopic examination by two physicians on GERD patients diagnosed by gastroenterology department by endoscopy and effect of GERD treatment for 3 months on these laryngeal disorders without any treatment to laryngeal disorders
- Conditions
- Laryngeal Disease
- Being tested
- Laryngoscopy
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaryngoscopyDevice
Laryngoscopic examination of patients with GERD by two physicians
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of laryngeal disorders in GERD patients
Laryngoscopic examination of patients with GERD by two otorhinolaryngologist physicians
Measured: One year from February 2020 to February 2021
Secondary outcomes (1)
Effect of treatment of GERD on these laryngeal disorders
Treatment of GERD by gastroenterology department for 3 months and reexamination of patients by laryngoscopy for laryngeal disorders without any treatment to laryngeal disorders
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jan 2021
- Primary completion1 May 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laryngeal DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHimaa Salah Sadek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231344
- Sponsor's protocol ID
- LPRD
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen JT, Bach KK, Postma GN, Koufman JA. Clinical manifestations of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):19-23.
PubMed 12353427Belafsky PC, Postma GN, Amin MR, Koufman JA. Symptoms and findings of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):10-3.
PubMed 12353425
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Laryngeal Disorders in Patients With GERD in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04231344
- Acronym / sponsor ID
- LPRD
- Conditions
- Laryngeal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Jan 2020 (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.
Study laryngeal disorders by laryngoscopic examination by two physicians on GERD patients diagnosed by gastroenterology department by endoscopy and effect of GERD treatment for 3 months on these laryngeal disorders without any treatment to laryngeal disorders
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who diagnosed GERD by gastroenterology department before start of treatment of GERD Will examine by laryngoscopy for laryngeal lesions then they Will take treatment to GERD by gastroenterology department without any treatment to laryngeal disorders and study effect of GERD treatment on these laryngeal disorders
Key inclusion criteria (1 listed)
- Patients diagnosed GERD by gastroenterology department before start of treatment and have laryngeal symptoms
Key exclusion criteria (1 listed)
- voice abusers as singers ,teachers and readers.
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 |
|---|---|---|
| LaryngoscopyLaryngoscopic examination of patients with GERD by two physicians | Device | – |
Primary outcome
Prevalence of laryngeal disorders in GERD patients
Time frame: One year from February 2020 to February 2021
Laryngoscopic examination of patients with GERD by two otorhinolaryngologist physicians
1 secondary outcome
Effect of treatment of GERD on these laryngeal disorders
Time frame: 3 months
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 28 Mar 2022.
- Background: PubMed 12353427Cohen JT, Bach KK, Postma GN, Koufman JA. Clinical manifestations of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):19-23.
- Background: PubMed 12353425Belafsky PC, Postma GN, Amin MR, Koufman JA. Symptoms and findings of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):10-3.
Related trials for Laryngeal Disease
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
Cough
RecruitingEarly Phase 1
PET/CT Assessment of Radiation-Induced Vascular Complications in Head and Neck Cancer
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Disease, run by Assiut University at 1 site 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 1 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of laryngeal disorders in GERD patients (time frame: One year from February 2020 to February 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231344, which also lists 2 linked publications.
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 28 Mar 2022.