Health, SubjectiveNCT03311893
Determine the Point of View of Society Society to Natural Orifice Surgeon
A study testing natural orifice surgery in people with Health, Subjective, run by Inonu University.
Trial summary
200 participants' perception and acceptability of natural hole surgeon Read more about this study
- Who is it for?
- Ages 17 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- natural orifice surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2016to 10 Aug 2017
- 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 17 to 100 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all female (health personnel and population)
Who cannot join
- none
About this study
Official title: the Rate of Awareness and Acceptability of Natural Orifice Surgeon in Middle Eastern Society is Similar to Other Studies
200 participants' perception and acceptability of natural hole surgeon
Read the detailed description
100 participants health personnel 100 participants population two group's perception and acceptability of natural orifice surgeon
- Conditions
- Health, Subjective
- Being tested
- natural orifice surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural orifice surgeryProcedure or surgery
evaluation of the awareness of the use of transvaginal, transoral and transcranial approach in surgical excision and the difference between the health staff and the pathology
| Study group | Role | What they receive |
|---|---|---|
| health personnel | Active comparator | natural orifice surgery evaluation of the awareness of the use of transvaginal, transoral and trananal approach in surgical excision and the difference between the health staff and population Receives: Procedure: natural orifice surgery |
| population | Placebo comparator | natural orifice surgery evaluation of the awareness of the use of transvaginal, transoral and trananal approach in surgical excision and the difference between the health staff and population Receives: Procedure: natural orifice surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
natural orifice surgery
a survey study that measures the awareness of natural orifice surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start10 Oct 2016
- Primary completion10 Jul 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Gündoğan, Inonu University
- Investigators
- Ersin Gündoğan, MD, Principal investigator, Inonu Unıversity- general surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311893
- Sponsor's protocol ID
- 2016/199
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Rate of Awareness and Acceptability of Natural Orifice Surgeon in Middle Eastern Society is Similar to Other Studies
- ClinicalTrials.gov ID
- NCT03311893
- Acronym / sponsor ID
- 2016/199
- Conditions
- Health, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 17 Oct 2017 (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.
200 participants' perception and acceptability of natural hole surgeon
Detailed description
100 participants health personnel 100 participants population two group's perception and acceptability of natural orifice surgeon
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health personnel | Active comparator | Procedure: natural orifice surgerynatural orifice surgery evaluation of the awareness of the use of transvaginal, transoral and trananal approach in surgical excision and the difference between the health staff and population |
| population | Placebo comparator | Procedure: natural orifice surgerynatural orifice surgery evaluation of the awareness of the use of transvaginal, transoral and trananal approach in surgical excision and the difference between the health staff and population |
Who may qualify
- Ages
- 17 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all female (health personnel and population)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| natural orifice surgeryevaluation of the awareness of the use of transvaginal, transoral and transcranial approach in surgical excision and the difference between the health staff and the pathology | Procedure or surgery | health personnel, population |
Primary outcome
natural orifice surgery
Time frame: 12 months
a survey study that measures the awareness of natural orifice surgery
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 17 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ersin Gündoğan, MD principal investigator
Inonu Unıversity- general surgery
Questions about this trial
What is this clinical trial studying?
A study testing natural orifice surgery in people with Health, Subjective, run by Inonu University.
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 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
natural orifice surgery (time frame: 12 months). 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 17 Oct 2017.