Ventrogluteal InjectionNCT07827300
Ultrasound-Guided Assessment of Ventrogluteal Intramuscular Injection in Adults With High BMI
A study testing Ventrogluteal Intramuscular Injection Using a 40 mm Needle in people with Ventrogluteal Injection and Nursing Care, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the ventrogluteal site for intramuscular injection in adults with a body mass index of 25 kg/m² or higher. Ultrasound was used to measure subcutaneous tissue, muscle, and total tissue thickness at the injection site and the distances from the injection point to anatomical landmarks and the sciatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventrogluteal Injection, Nursing Care
- What is being tested?
- Ventrogluteal Intramuscular Injection Using a 40 mm Needle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Aug 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and <75 years.
- Body mass index >24.9 kg/m².
- A clinical order for intramuscular administration of 1 mL cyanocobalamin at a concentration of 1000 mcg/mL.
- No muscle atrophy or motor or sensory loss associated with neurological or muscular pathology.
- Able to walk independently or with assistance and perform activities of daily living.
Who cannot join
- Degenerative muscle diseases or motor neuron diseases.
- Amyotrophic lateral sclerosis or other progressive neuromuscular diseases.
- Severe muscle atrophy or motor function loss that could affect the reliability of ultrasonographic muscle-thickness measurements.
- Muscle structure considered unsuitable for reliable ultrasonographic measurement or presence of motor/sensory function loss on clinical evaluation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul, Eyalet/Yerleşke, 34000
About this study
Official title: Ventrogluteal Intramuscular Injection in Individuals With High Body Mass Index: Ultrasound-Based Anatomical Measurements and Evaluation of Safe Intramuscular Placement of a 40 mm Needle
This study evaluated the ventrogluteal site for intramuscular injection in adults with a body mass index of 25 kg/m² or higher. Ultrasound was used to measure subcutaneous tissue, muscle, and total tissue thickness at the injection site and the distances from the injection point to anatomical landmarks and the sciatic nerve. During intramuscular injection with a 40 mm needle, real-time ultrasound was used to visualize the needle tip and assess its position within the muscle. The study also evaluated successful intramuscular placement, subcutaneous medication leakage, and injection-related complications. The findings were assessed across three body mass index groups.
- Conditions
- Ventrogluteal Injection, Nursing Care
- Being tested
- Ventrogluteal Intramuscular Injection Using a 40 mm Needle
- Keywords
- Body Mass Index, Ventrogluteal Site, Intramuscular Injection, G Method, Needle Length, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventrogluteal Intramuscular Injection Using a 40 mm NeedleProcedure or surgery
Participants received a ventrogluteal intramuscular injection of 1 mL cyanocobalamin (1000 mcg/mL) using a 40 mm, 21-gauge needle. The injection site was identified using the G method. During the injection, the needle tip was visualized in real time using ultrasonography to evaluate its intramuscular position, including its distance from the superficial muscle fascia and the ilium. The position of the needle tip relative to the sciatic nerve was also assessed.
| Study group | Role | What they receive |
|---|---|---|
| Ventrogluteal Intramuscular Injection | Experimental | Participants received a ventrogluteal intramuscular injection of 1 mL cyanocobalamin (1000 mcg/mL) using a 40 mm, 21-gauge needle. The injection site was identified using the G method. During the injection, the needle tip was visualized using real-time ultrasonography to assess its intramuscular position and its distances from relevant anatomical structures. Receives: Procedure: Ventrogluteal Intramuscular Injection Using a 40 mm Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successful Intramuscular Placement of the 40 mm Needle
The percentage of participants in whom the 40 mm needle met the predefined intramuscular placement criteria was assessed using real-time ultrasonography. Successful intramuscular placement was defined as the needle tip being at least 10 mm beneath the superficial muscle fascia and at least 10 mm away from the iliac cortex.
Measured: During the injection procedure, immediately after full insertion of the needle and before medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Apr 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventrogluteal InjectionStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Kaynar Şimşek, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827300
- Sponsor's protocol ID
- 325S418
- Other IDs
- 325S418
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventrogluteal Intramuscular Injection in Individuals With High Body Mass Index: Ultrasound-Based Anatomical Measurements and Evaluation of Safe Intramuscular Placement of a 40 mm Needle
- ClinicalTrials.gov ID
- NCT07827300
- Acronym / sponsor ID
- 325S418
- Conditions
- Ventrogluteal Injection, Nursing Care
- Keywords
- Body Mass Index, Ventrogluteal Site, Intramuscular Injection, G Method, Needle Length, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 18 Sep 2026 (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 evaluated the ventrogluteal site for intramuscular injection in adults with a body mass index of 25 kg/m² or higher. Ultrasound was used to measure subcutaneous tissue, muscle, and total tissue thickness at the injection site and the distances from the injection point to anatomical landmarks and the sciatic nerve. During intramuscular injection with a 40 mm needle, real-time ultrasound was used to visualize the needle tip and assess its position within the muscle. The study also evaluated successful intramuscular placement, subcutaneous medication leakage, and injection-related complications. The findings were assessed across three body mass index groups.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventrogluteal Intramuscular Injection | Experimental | Procedure: Ventrogluteal Intramuscular Injection Using a 40 mm NeedleParticipants received a ventrogluteal intramuscular injection of 1 mL cyanocobalamin (1000 mcg/mL) using a 40 mm, 21-gauge needle. The injection site was identified using the G method. During the injection, the needle tip was visualized using real-time ultrasonography to assess its intramuscular position and its distances from relevant anatomical structures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 and <75 years.
- Body mass index >24.9 kg/m².
- A clinical order for intramuscular administration of 1 mL cyanocobalamin at a concentration of 1000 mcg/mL.
- No muscle atrophy or motor or sensory loss associated with neurological or muscular pathology.
- Able to walk independently or with assistance and perform activities of daily living.
Key exclusion criteria (4 listed)
- Degenerative muscle diseases or motor neuron diseases.
- Amyotrophic lateral sclerosis or other progressive neuromuscular diseases.
- Severe muscle atrophy or motor function loss that could affect the reliability of ultrasonographic muscle-thickness measurements.
- Muscle structure considered unsuitable for reliable ultrasonographic measurement or presence of motor/sensory function loss on clinical evaluation.
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 |
|---|---|---|
| Ventrogluteal Intramuscular Injection Using a 40 mm NeedleParticipants received a ventrogluteal intramuscular injection of 1 mL cyanocobalamin (1000 mcg/mL) using a 40 mm, 21-gauge needle. The injection site was identified using the G method. During the injection, the needle tip was visualized in real time using ultrasonography to evaluate its intramuscular position, including its distance from the superficial muscle fascia and the ilium. The position of the needle tip relative to the sciatic nerve was also assessed. | Procedure or surgery | Ventrogluteal Intramuscular Injection |
Primary outcome
Percentage of Participants With Successful Intramuscular Placement of the 40 mm Needle
Time frame: During the injection procedure, immediately after full insertion of the needle and before medication administration
The percentage of participants in whom the 40 mm needle met the predefined intramuscular placement criteria was assessed using real-time ultrasonography. Successful intramuscular placement was defined as the needle tip being at least 10 mm beneath the superficial muscle fascia and at least 10 mm away from the iliac cortex.
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 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Ventrogluteal Injection
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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.
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?
A study testing Ventrogluteal Intramuscular Injection Using a 40 mm Needle in people with Ventrogluteal Injection and Nursing Care, run by Marmara University 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 5 inclusion and 4 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 18 Sep 2026. 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?
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?
Percentage of Participants With Successful Intramuscular Placement of the 40 mm Needle (time frame: During the injection procedure, immediately after full insertion of the needle and before medication administration). 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 18 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.