Prostate CancerTRUSNCT07156747
The Impact of Video Education on Pain and Anxiety in Patients Undergoing Transrectal Ultrasonography-Guided Prostate Biopsy
A study testing Visual Analog Scale, State-Trait Anxiety Inventory and Video in people with Prostate Cancer and Prostate Biopsy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to assess the impact of dynamic video education versus static images and verbal instruction on pain perception and anxiety in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUS-Bx). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Biopsy, Anxiety
- What is being tested?
- Visual Analog Scale, State-Trait Anxiety Inventory and Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2023to 20 May 2025
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men between 50 and 80 years of age
- Elevated prostate-specific antigen (PSA) levels and/or suspicious digital rectal examination (DRE) findings
- Literacy and comprehension
Who cannot join
- A history of previous prostate biopsy
- Cognitive or psychiatric disorders
- Using anxiolytic medications
- After being informed, declining to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
Official title: Evaluate the Impact of Dynamic Video Education Versus Static Images and Verbal Instruction on Pain Perception and Anxiety in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy (TRUS-Bx).
This study aimed to assess the impact of dynamic video education versus static images and verbal instruction on pain perception and anxiety in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUS-Bx).
Participants were allocated to three groups: control (verbal information), video (verbal information accompanied by dynamic video), and image (verbal information supplemented by static images). Pain intensity was quantified utilizing the Visual Analog Scale (VAS), while anxiety was evaluated with the State-Trait Anxiety Inventory (STAI) prior to and following the surgery.
Read the detailed description
Prostate cancer is among the most common malignancies diagnosed globally and constitutes the second highest cause of cancer-related mortality in males. Timely identification is crucial for enhancing clinical results, directing suitable therapy alternatives, and ultimately elevating survival rates. Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) is the definitive diagnostic method for acquiring tissue samples from suspected prostate lesions. This method is preferred because of its comparatively low expense, extensive accessibility, and significant diagnostic efficacy.
Although categorized as a minimally invasive technique, TRUS-Bx can induce significant psychological anguish in patients. Pre-procedural anxiety is prevalent and can stem from various factors: dread of discomfort related with the biopsy, concern regarding a possible cancer diagnosis, and lack of familiarity or misunderstanding about the biopsy procedure. This worry is not solely an emotional concern; it can negatively impact physiological metrics such as blood pressure and heart rate, heighten the perceived discomfort during the surgery, and diminish patient compliance. Furthermore, elevated anxiety levels are associated with diminished patient satisfaction and can adversely affect patients' readiness to pursue essential medical procedures in the future, potentially resulting in long-term health repercussions.
Reducing preoperative anxiety is essential for patient-centered treatment in procedural medicine. Effective educational interventions have demonstrated the capacity to alleviate anxiety by improving patient comprehension and establishing reasonable expectations. Conventional approaches encompass oral elucidations by healthcare professionals and printed pamphlets, whose efficacy fluctuates owing to disparities in literacy, attention, and retention among patients. Visual aids, particularly educational movies, provide a multimodal learning experience by integrating aural narrative with dynamic visuals, which may enhance understanding and engagement.
Prior studies on diverse medical procedures, including colonoscopy, endoscopy, and small surgical interventions, have shown that video-based teaching can markedly boost patients' understanding, alleviate anxiety, and improve overall satisfaction with the care experience. Nonetheless, despite the prevalent application of TRUS-Bx, there is a scarcity of data investigating the particular influence of video education in this domain. Moreover, it is uncertain whether dynamic video content (e.g., animated or actual procedural footage) provides benefits over static visuals or verbal information alone in mitigating anxiety and perceived pain associated with prostate biopsy.
Moreover, due to the growing accessibility of internet video platforms such as YouTube, individuals frequently pursue information autonomously before undergoing medical operations. Although this can empower patients, the quality and accuracy of such content fluctuate significantly, potentially affecting their psychological condition in unforeseen manners.
Research Aim
This study seeks to systematically assess the impact of pre-procedural video education regarding TRUS-Bx on patients' anxiety and subjective pain levels. The researchers aim to compare the impact of dynamic, detailed videos-akin to those found on popular platforms such as YouTube-with static image displays or traditional spoken therapy. The fundamental premise posits that exposure to extensive, dynamic video information before biopsy will adequately prepare patients by clarifying the technique, therefore alleviating psychological discomfort and enhancing their overall experience.
This study aims to clarify the function of video-based instructional aids in the clinical environment, intending to guide best practices for patient education and aid in the formulation of standardized procedures to enhance patient-centered outcomes in prostate cancer diagnosis.
- Conditions
- Prostate Cancer, Prostate Biopsy, Anxiety
- Being tested
- Visual Analog Scale, State-Trait Anxiety Inventory, Video, Image
- Keywords
- Prostate Biopsy, Video Education, Pain Perception, Anxiety, Patient Preparation
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analog ScaleOther
The Visual Analog Scale (VAS) is a linear instrument employed to measure perceived pain intensity, spanning from 0 (indicating no pain) to 10 (representing the most severe pain), where patients indicate the level that most accurately represents their experience.
State-Trait Anxiety InventoryOther
The STAI is a self-administered questionnaire with two parts: STAI-1 measures state anxiety, representing a transient emotional state triggered by a particular circumstance, while STAI-2 examines trait anxiety, denoting a consistent predisposition to experience anxiety across diverse situations.
VideoOther
watching video on Digital Platfrom (for example, Youtube)
ImageOther
Prostate biopsy information with images
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | The control group received verbal information regarding the biopsy procedure. Receives: Other: Visual Analog Scale; Other: State-Trait Anxiety Inventory |
| Video Group | Experimental | The Video Group viewed a brief video about TRUS-Bx that was sourced from a frequently utilized video-sharing platform. Receives: Other: Visual Analog Scale; Other: State-Trait Anxiety Inventory; Other: Video |
| Image Group | Experimental | The image group (Image Group) was provided with information and still images that depicted the biopsy procedure. Receives: Other: Visual Analog Scale; Other: State-Trait Anxiety Inventory; Other: Image |
What is being measured
The primary outcome is the main question the study is designed to answer.
The importance of biopsy procedure information
The research indicates that an increase in patients' anxiety-stress ratings will require the implementation of supplementary measures to notify patients prior to the treatment. Patients who decline the surgery may encounter delays in diagnosis and treatment, or these may be entirely omitted, owing to the visual information and videos acquired prior to the procedure. This study will additionally function as a reference for image alteration on digital platforms. By assessing the levels of anxiety and discomfort induced by visual and verbal input, modifications can be implemented in the information processes related to the procedure.
Measured: Through study completion, an average of 1 year
Assessment of pain intensity associated with the biopsy operation
The Visual Analog Scale (VAS) is a linear measurement tool used to assess perceived pain intensity, ranging from 0 (indicating no pain) to 10 (representing the most severe pain), where patients indicate the level that most accurately represents their experience. All measurements were conducted in a tranquil environment immediately prior to and following the biopsy process.
Measured: Through study completion, an average of 1 year]
Evaluation of anxiety levels related to the biopsy procedure
The STAI is a self-administered questionnaire with two elements: STAI-1 measures state anxiety, representing a transient emotional state elicited by a particular circumstance, while STAI-2 examines trait anxiety, signifying a consistent predisposition to experience anxiety across diverse situations. State-Trait Anxiety Inventory, Form 1 and Form 2 (STAI-1 and STAI-2). It is a Likert scale. The cumulative score derived from both measures runs from 20 (indicating mild anxiety) to 80 (indicating excessive anxiety). Diverse scoring methodologies are available for STAI-1 and STAI-2 scores.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start10 Dec 2023
- Primary completion30 Dec 2024
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were categorized into three groups. The control group received verbal information regarding the biopsy procedure. The film Group received a same verbal explanation and viewed a brief film regarding TRUS-Bx sourced from a widely utilized video-sharing platform. The picture group received verbal information accompanied by still photographs depicting the biopsy procedure. Participants in this trial were not randomized. Rather, they were allocated to groups according to their socioeconomic level. This was implemented to deliver education tailored to each patient's background and comprehension. All teaching initiatives were administered by the same qualified urology nurse to maintain consistency. A panel of urologists pre-selected the video and graphic elements for clarity, accuracy, and educational value.
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatih SANDIKCI, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156747
- Sponsor's protocol ID
- AESH-U-FS-01
- Acronym
- TRUS
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tarhan H, Cakmak O, Unal E, Akarken I, Un S, Ekin RG, Konyalioglu E, Isoglu CS, Zorlu F. The effect of video-based education on patient anxiety in men undergoing transrectal prostate biopsy. Can Urol Assoc J. 2014 Nov;8(11-12):E894-900. doi: 10.5489/cuaj.2208.
PubMed 25553162Sheng LP, Han CQ, Nie C, Xu T, Zhang K, Li XJ, Xie XR, Lin R, Ding Z. Watching Videos of Colonoscopies and Receiving Interpretations Reduce Pain and Anxiety While Increasing the Satisfaction of Patients. Dig Dis Sci. 2021 Feb;66(2):541-546. doi: 10.1007/s10620-020-06186-6. Epub 2020 Mar 19.
PubMed 32193861Bujnowska-Fedak MM, Wegierek P. The Impact of Online Health Information on Patient Health Behaviours and Making Decisions Concerning Health. Int J Environ Res Public Health. 2020 Jan 31;17(3):880. doi: 10.3390/ijerph17030880.
PubMed 32023828Monteiro Grilo A, Ferreira AC, Pedro Ramos M, Carolino E, Filipa Pires A, Vieira L. Effectiveness of educational videos on patient's preparation for diagnostic procedures: Systematic review and Meta-Analysis. Prev Med Rep. 2022 Jul 5;28:101895. doi: 10.1016/j.pmedr.2022.101895. eCollection 2022 Aug.
PubMed 35855928Sefik E, Gunlusoy B, Eker A, Celik S, Ceylan Y, Koskderelioglu A, Basmaci I, Degirmenci T. Anxiety and depression associated with a positive prostate biopsy result: A comparative, prospective cohort study. Int Braz J Urol. 2020 Nov-Dec;46(6):993-1005. doi: 10.1590/S1677-5538.IBJU.2019.0719.
PubMed 32822128
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Impact of Dynamic Video Education Versus Static Images and Verbal Instruction on Pain Perception and Anxiety in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy (TRUS-Bx).
- ClinicalTrials.gov ID
- NCT07156747
- Acronym / sponsor ID
- TRUS / AESH-U-FS-01
- Conditions
- Prostate Cancer, Prostate Biopsy, Anxiety
- Keywords
- Prostate Biopsy, Video Education, Pain Perception, Anxiety, Patient Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 5 Sep 2025 (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 aimed to assess the impact of dynamic video education versus static images and verbal instruction on pain perception and anxiety in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUS-Bx).
Participants were allocated to three groups: control (verbal information), video (verbal information accompanied by dynamic video), and image (verbal information supplemented by static images). Pain intensity was quantified utilizing the Visual Analog Scale (VAS), while anxiety was evaluated with the State-Trait Anxiety Inventory (STAI) prior to and following the surgery.
Detailed description
Prostate cancer is among the most common malignancies diagnosed globally and constitutes the second highest cause of cancer-related mortality in males. Timely identification is crucial for enhancing clinical results, directing suitable therapy alternatives, and ultimately elevating survival rates. Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) is the definitive diagnostic method for acquiring tissue samples from suspected prostate lesions. This method is preferred because of its comparatively low expense, extensive accessibility, and significant diagnostic efficacy.
Although categorized as a minimally invasive technique, TRUS-Bx can induce significant psychological anguish in patients. Pre-procedural anxiety is prevalent and can stem from various factors: dread of discomfort related with the biopsy, concern regarding a possible cancer diagnosis, and lack of familiarity or misunderstanding about the biopsy procedure. This worry is not solely an emotional concern; it can negatively impact physiological metrics such as blood pressure and heart rate, heighten the perceived discomfort during the surgery, and diminish patient compliance. Furthermore, elevated anxiety levels are associated with diminished patient satisfaction and can adversely affect patients' readiness to pursue essential medical procedures in the future, potentially resulting in long-term health repercussions.
Reducing preoperative anxiety is essential for patient-centered treatment in procedural medicine. Effective educational interventions have demonstrated the capacity to alleviate anxiety by improving patient comprehension and establishing reasonable expectations. Conventional approaches encompass oral elucidations by healthcare professionals and printed pamphlets, whose efficacy fluctuates owing to disparities in literacy, attention, and retention among patients. Visual aids, particularly educational movies, provide a multimodal learning experience by integrating aural narrative with dynamic visuals, which may enhance understanding and engagement.
Prior studies on diverse medical procedures, including colonoscopy, endoscopy, and small surgical interventions, have shown that video-based teaching can markedly boost patients' understanding, alleviate anxiety, and improve overall satisfaction with the care experience. Nonetheless, despite the prevalent application of TRUS-Bx, there is a scarcity of data investigating the particular influence of video education in this domain. Moreover, it is uncertain whether dynamic video content (e.g., animated or actual procedural footage) provides benefits over static visuals or verbal information alone in mitigating anxiety and perceived pain associated with prostate biopsy.
Moreover, due to the growing accessibility of internet video platforms such as YouTube, individuals frequently pursue information autonomously before undergoing medical operations. Although this can empower patients, the quality and accuracy of such content fluctuate significantly, potentially affecting their psychological condition in unforeseen manners.
Research Aim
This study seeks to systematically assess the impact of pre-procedural video education regarding TRUS-Bx on patients' anxiety and subjective pain levels. The researchers aim to compare the impact of dynamic, detailed videos-akin to those found on popular platforms such as YouTube-with static image displays or traditional spoken therapy. The fundamental premise posits that exposure to extensive, dynamic video information before biopsy will adequately prepare patients by clarifying the technique, therefore alleviating psychological discomfort and enhancing their overall experience.
This study aims to clarify the function of video-based instructional aids in the clinical environment, intending to guide best practices for patient education and aid in the formulation of standardized procedures to enhance patient-centered outcomes in prostate cancer diagnosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were categorized into three groups. The control group received verbal information regarding the biopsy procedure. The film Group received a same verbal explanation and viewed a brief film regarding TRUS-Bx sourced from a widely utilized video-sharing platform. The picture group received verbal information accompanied by still photographs depicting the biopsy procedure. Participants in this trial were not randomized. Rather, they were allocated to groups according to their socioeconomic level. This was implemented to deliver education tailored to each patient's background and comprehension. All teaching initiatives were administered by the same qualified urology nurse to maintain consistency. A panel of urologists pre-selected the video and graphic elements for clarity, accuracy, and educational value.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Visual Analog Scale, Other: State-Trait Anxiety InventoryThe control group received verbal information regarding the biopsy procedure. |
| Video Group | Experimental | Other: Visual Analog Scale, Other: State-Trait Anxiety Inventory, Other: VideoThe Video Group viewed a brief video about TRUS-Bx that was sourced from a frequently utilized video-sharing platform. |
| Image Group | Experimental | Other: Visual Analog Scale, Other: State-Trait Anxiety Inventory, Other: ImageThe image group (Image Group) was provided with information and still images that depicted the biopsy procedure. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men between 50 and 80 years of age
- Elevated prostate-specific antigen (PSA) levels and/or suspicious digital rectal examination (DRE) findings
- Literacy and comprehension
Key exclusion criteria (4 listed)
- A history of previous prostate biopsy
- Cognitive or psychiatric disorders
- Using anxiolytic medications
- After being informed, declining to participate in the study
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 |
|---|---|---|
| Visual Analog ScaleThe Visual Analog Scale (VAS) is a linear instrument employed to measure perceived pain intensity, spanning from 0 (indicating no pain) to 10 (representing the most severe pain), where patients indicate the level that most accurately represents their experience. | Other | Control Group, Image Group, Video Group |
| State-Trait Anxiety InventoryThe STAI is a self-administered questionnaire with two parts: STAI-1 measures state anxiety, representing a transient emotional state triggered by a particular circumstance, while STAI-2 examines trait anxiety, denoting a consistent predisposition to experience anxiety across diverse situations. | Other | Control Group, Image Group, Video Group |
| Videowatching video on Digital Platfrom (for example, Youtube) | Other | Video Group |
| ImageProstate biopsy information with images | Other | Image Group |
Primary outcome
The importance of biopsy procedure information
Time frame: Through study completion, an average of 1 year
The research indicates that an increase in patients' anxiety-stress ratings will require the implementation of supplementary measures to notify patients prior to the treatment. Patients who decline the surgery may encounter delays in diagnosis and treatment, or these may be entirely omitted, owing to the visual information and videos acquired prior to the procedure. This study will additionally function as a reference for image alteration on digital platforms. By assessing the levels of anxiety and discomfort induced by visual and verbal input, modifications can be implemented in the information processes related to the procedure.
Assessment of pain intensity associated with the biopsy operation
Time frame: Through study completion, an average of 1 year]
The Visual Analog Scale (VAS) is a linear measurement tool used to assess perceived pain intensity, ranging from 0 (indicating no pain) to 10 (representing the most severe pain), where patients indicate the level that most accurately represents their experience. All measurements were conducted in a tranquil environment immediately prior to and following the biopsy process.
Evaluation of anxiety levels related to the biopsy procedure
Time frame: Through study completion, an average of 1 year
The STAI is a self-administered questionnaire with two elements: STAI-1 measures state anxiety, representing a transient emotional state elicited by a particular circumstance, while STAI-2 examines trait anxiety, signifying a consistent predisposition to experience anxiety across diverse situations. State-Trait Anxiety Inventory, Form 1 and Form 2 (STAI-1 and STAI-2). It is a Likert scale. The cumulative score derived from both measures runs from 20 (indicating mild anxiety) to 80 (indicating excessive anxiety). Diverse scoring methodologies are available for STAI-1 and STAI-2 scores.
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 5 Sep 2025.
- Results publication: PubMed 25553162Tarhan H, Cakmak O, Unal E, Akarken I, Un S, Ekin RG, Konyalioglu E, Isoglu CS, Zorlu F. The effect of video-based education on patient anxiety in men undergoing transrectal prostate biopsy. Can Urol Assoc J. 2014 Nov;8(11-12):E894-900. doi: 10.5489/cuaj.2208.
- Results publication: PubMed 32193861Sheng LP, Han CQ, Nie C, Xu T, Zhang K, Li XJ, Xie XR, Lin R, Ding Z. Watching Videos of Colonoscopies and Receiving Interpretations Reduce Pain and Anxiety While Increasing the Satisfaction of Patients. Dig Dis Sci. 2021 Feb;66(2):541-546. doi: 10.1007/s10620-020-06186-6. Epub 2020 Mar 19.
- Results publication: PubMed 32023828Bujnowska-Fedak MM, Wegierek P. The Impact of Online Health Information on Patient Health Behaviours and Making Decisions Concerning Health. Int J Environ Res Public Health. 2020 Jan 31;17(3):880. doi: 10.3390/ijerph17030880.
- Results publication: PubMed 35855928Monteiro Grilo A, Ferreira AC, Pedro Ramos M, Carolino E, Filipa Pires A, Vieira L. Effectiveness of educational videos on patient's preparation for diagnostic procedures: Systematic review and Meta-Analysis. Prev Med Rep. 2022 Jul 5;28:101895. doi: 10.1016/j.pmedr.2022.101895. eCollection 2022 Aug.
- Results publication: PubMed 32822128Sefik E, Gunlusoy B, Eker A, Celik S, Ceylan Y, Koskderelioglu A, Basmaci I, Degirmenci T. Anxiety and depression associated with a positive prostate biopsy result: A comparative, prospective cohort study. Int Braz J Urol. 2020 Nov-Dec;46(6):993-1005. doi: 10.1590/S1677-5538.IBJU.2019.0719.
- Individual participant dataSharing planned: No
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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 Visual Analog Scale, State-Trait Anxiety Inventory and Video in people with Prostate Cancer and Prostate Biopsy, run by Ankara Etlik City 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 3 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 5 Sep 2025. 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?
The importance of biopsy procedure information (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 NCT07156747, which also lists 5 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 5 Sep 2025.