ThyroidbluethyroidNCT01347606
Secured Thyroidectomy With Intraoperative Methylene Blue Using
An observational study of Thyroid, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Jul 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: thyroidectomy indicated patients
Who may be able to join
- Thyroidectomy indicated patients
Who cannot join
- Recurrent disease
- Additional disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul
adnan yuksel, Prof, +902124531700, ayuksel@bezmialem.edu.tr
About this study
Official title: Prospective Randomized Technical Study
Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using.
Read the detailed description
Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using. In the operation when thyroid lobes manipulated to medially, methylene blue will be sprayed to this area. Dying patternes of tissues (thyroid tissue, oparathyroid tissues, arteries, venules and neural structures) will ensure to identification the tissues.
- Conditions
- Thyroid
- Keywords
- thyroid, secure, surgery, methylene, blue
- Medical subject headings
- Thyroid Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Investigators
- erhan aysan, Assoc. Prof., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347606
- Sponsor's protocol ID
- 4-Aysan
- Acronym
- bluethyroid
- Status last verified
- Jan 2010
- First submitted
- 3 May 2011
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Technical Study
- ClinicalTrials.gov ID
- NCT01347606
- Acronym / sponsor ID
- bluethyroid / 4-Aysan
- Conditions
- Thyroid
- Keywords
- thyroid, secure, surgery, methylene, blue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 4 May 2011 (estimated)
- 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.
Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using.
Detailed description
Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction and vascular or neural (such as recurrent nervus) injuries are most important ones. This research is aim to prevention of these via intraoperative methylene blue using. In the operation when thyroid lobes manipulated to medially, methylene blue will be sprayed to this area. Dying patternes of tissues (thyroid tissue, oparathyroid tissues, arteries, venules and neural structures) will ensure to identification the tissues.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- thyroidectomy indicated patients
Key inclusion criteria (1 listed)
- Thyroidectomy indicated patients
Key exclusion criteria (2 listed)
- Recurrent disease
- Additional disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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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.
erhan aysan, Assoc. Prof. principal investigator
Bezmialem Vakif University
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 Thyroid, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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 4 May 2011. 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 4 May 2011.