Safety and Cosmetic Issues in Endoscopic ThyroidectomyThyroidectomyNCT04329455
Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules
An observational study of Safety and Cosmetic Issues in Endoscopic Thyroidectomy, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Cosmetic Issues in Endoscopic Thyroidectomy
- What is being tested?
- Endoscopic thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 1 Apr 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 30 patients age group 18_55 years with unilateral or bilateral thyroid nodules benign according to preoperative FNAC and normal thyroid function
Who may be able to join
- benign thyroid nodules unilateral or bilateral Normal thyroid function
Who cannot join
- malignant Thyroid Nodules Recurrent goitre Toxic goitre
Trial locations and contacts
1 site in 1 country.
Ahmed Mohamed Gamal contact
About this study
Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes
- Being tested
- Endoscopic thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic thyroidectomyProcedure or surgery
Endoscopic thyroidectomy in Thyroid Nodules
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Not described Receives: Procedure: Endoscopic thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Endoscopic Thyroidectomy
Measured: 2020_2023
Secondary outcomes (1)
Cosmetic outcome of Endoscopic Thyroidectomy
Measured: 2020_2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Cosmetic Issues in Endoscopic ThyroidectomyStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Hemdan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329455
- Sponsor's protocol ID
- Ahmed1989
- Acronym
- Thyroidectomy
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- 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 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules
- ClinicalTrials.gov ID
- NCT04329455
- Acronym / sponsor ID
- Thyroidectomy / Ahmed1989
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 1 Apr 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.
Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Procedure: Endoscopic thyroidectomy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 patients age group 18_55 years with unilateral or bilateral thyroid nodules benign according to preoperative FNAC and normal thyroid function
Key inclusion criteria (1 listed)
- benign thyroid nodules unilateral or bilateral Normal thyroid function
Key exclusion criteria (1 listed)
- malignant Thyroid Nodules Recurrent goitre Toxic goitre
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 |
|---|---|---|
| Endoscopic thyroidectomyEndoscopic thyroidectomy in Thyroid Nodules | Procedure or surgery | Intervention group |
Primary outcome
Safety of Endoscopic Thyroidectomy
Time frame: 2020_2023
1 secondary outcome
Cosmetic outcome of Endoscopic Thyroidectomy
Time frame: 2020_2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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.
Ahmed Mohamed Gamal contact
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 Safety and Cosmetic Issues in Endoscopic Thyroidectomy, 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: status not confirmed, as of the sponsor's last update on 1 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed Gamal, MD (01069850499 ext. 71111, ahmedgamalgeneralsurgery@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Endoscopic Thyroidectomy (time frame: 2020_2023). 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 1 Apr 2020.