Sellar TumorPhase 2EEEA-AMSBPNCT07539792
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
A Phase 2 study testing Absorbable and moldable skull base support plate in people with Sellar Tumor and Endonasal Surgery, run by Nanfang Hospital, Southern Medical University at 8 sites in China.
Trial summary
Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery. Secondary objectives: 1. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Sellar Tumor, Endonasal Surgery, Csf Leakage
- What is being tested?
- Absorbable and moldable skull base support plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 8 sitesChina
- Study dates
- 1 Apr 2026to 28 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 1-80 years, regardless of gender;
- Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;
- Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;
- Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;
- Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;
- Sign the informed consent form and are willing to participate in the study.
Who cannot join
- Patients with other concurrent intracranial tumors or severe brain lesions;
- Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;
- Patients with uncontrolled severe heart, lung, kidney, or liver diseases;
- Pregnant or lactating women;
- Patients who have previously received radiotherapy or chemotherapy;
- Patients with active nasal infections, inflammation, or severe nasal diseases;
Show all 9Show fewer
- Patients with a history of severe allergies to drugs or synthetic materials;
- Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;
- Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
The First People's Hospital Of Foshan
Foshan, Guangdong
Lianxu Cui, +86-18038863001, cuilianxu@qq.com
Lianxu Cui
- Not yet recruiting
Gaozhou People's Hospital
Gaozhou, Guangdong
Linfan Li, +86-138 2488 0022
lmj1006@yeah.net
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Xiaobing Jiang, MD, Ph.D, +86-15201253009, jiangxiaob1@sysucc.org.cn
XIaobing Jiang, MD, Ph.D
- Recruiting
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou, Guangdong, 510515
Jun Pan, MD, Ph.D
Mingfeng Zhou, Ph.D
- Not yet recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Tao Huang, +86-18688898958, arteries@163.com
Tao Huang
- Not yet recruiting
Huizhou Central People's Hospital
Huizhou, Guangdong
Honghai Luo, Master of Medical Science, +86-15820717999, luohonghai999@sohu.com
Honghai Luo, Master of Medical Science
- Not yet recruiting
Liuzhou people's hospital
Liuzhou, Guangxi
Yuanliang Ye, +86-13667726163, yeyuanliangy@163.com
Yuanliang Ye
- Not yet recruiting
The First People's Hospital of Zhaoqing
Zhaoqing, Guangdong
Haibin Li, +86-13560917978, Lihaibin08@126.com
Haibin Li
About this study
Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery.
Secondary objectives:
- To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of intracranial infection within 1 months after surgery;
- To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the duration of the surgery and length of postoperative hospital stay;
- To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.
Read the detailed description
This is a multicenter, two-arm, open-label, randomized, controlled phase II clinical trial. It plans to enroll patients with sellar region tumors who will undergo extended endoscopic endonasal transsphenoidal approach. The aim is to compare the incidence of CSF rhinorrhea within 1 month after surgery between the combination of standard sellar floor repair + absorbable and moldable skull base support plate repair and the standard sellar floor repair group, and evaluate its safety and efficacy, so as to provide new strategies and basis for clinical treatment.
Statistical Analysis:
Analysis Sets:
Full Analysis Set (FAS), Per Protocol Set (PPS), and Safety Set (SS) will be used for statistical analysis.
- Full Analysis Set (FAS): Refers to the set of all subjects who have received the trial after enrollment and have undergone at least one efficacy assessment.
- Safety Set (SS):
Refers to the set of all subjects who have received the trial after enrollment and have undergone at least one safety indicator evaluation.
- Per Protocol Set (PPS): The set of cases in the Full Analysis Set that have completed the trial as specified in the protocol and have no serious violations of the trial protocol.
This is a phase II clinical trial. The sample size of this study will be calculated based on the hypothesis of a 1:1 parallel design sample rate in the two groups. The specific method is to compare the incidence of CSF rhinorrhea (CSF Leakage Rate, CLR) within 1 month after surgery in the experimental group (i.e., standard sellar floor repair + absorbable and moldable skull base support plate repair group) with that in the standard sellar floor repair group. It is assumed that the CLR in the experimental group is 1% (p1=0.01) and that in the standard sellar floor repair group is 15% (p2=0.15). The significance level is set at 0.025 (one-sided test), and the power is 80%. According to literature references and study design, we expect to recruit approximately 56 subjects in each group. Allowing for a 10% loss to follow-up, the sample size will be increased to N = 126 (63 subjects per group).
All statistical analyses will be performed using SAS 9.2 statistical analysis software.
Follow-up Face-to-face oral follow-up will be conducted for patients who return to the hospital for reexamination, and telephone follow-up will be conducted for patients who cannot return to the hospital for reexamination.
Statistical Methods
Data Processing:
Data processing and analysis will be performed using SAS 9.2 statistical analysis software. All continuous variables will be expressed as mean ± standard deviation (Mean ± SD) or median (interquartile range), and categorical variables will be expressed as frequency and percentage.
Analysis of Primary Efficacy Indicators:
Incidence of CSF rhinorrhea (CLR) within 1 month after surgery: Evaluated according to clinical symptoms, imaging, and nasal endoscopy standards. Chi-square test or Fisher's exact test will be used to analyze the CLR of each group.
Analysis of Secondary Efficacy Indicators:
- Incidence of intracranial infection within 1 month after surgery: Inter-group analysis will be performed using chi-square test or Fisher's exact test.
- Utilization rate of autologous fascia, fat, and nasal septum mucosal flaps: Inter-group analysis will be performed using chi-square test or Fisher's exact test.
- Length of duration of the surgery and postoperative hospital stay: Inter-group analysis will be performed using t-test or non-parametric test.
Safety Analysis:
Treatment-related adverse events will be evaluated according to the CTCAE 5.0 standard. The incidence of adverse events in each group will be analyzed using chi-square test or Fisher's exact test, and the frequency and severity of adverse events will be described by category.
Significance Level:
All statistical tests are two-sided tests, and the significance level is set at P < 0.05. P < 0.05 is considered statistically significant.
- Conditions
- Sellar Tumor, Endonasal Surgery, Csf Leakage
- Being tested
- Absorbable and moldable skull base support plate
- Keywords
- Sellar Tumor, Extended Endoscopic Endonasal Transsphenoidal Surgery, Cerebrospinal Fluid Rhinorrhea, Skull Base Reconstruction
- Medical subject headings
- Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable and moldable skull base support plateDevice
The sbsorbable and moldable skull base support plate is used during the skull base repair phase of the surgery.
Trimming: Measure the size of the skull base defect bone window (from the tuberculum sellae to the clival bone edge). Cut the malleable support plate slightly longer than this dimension.
Shaping: Shape the plate according to the morphological changes of the sellar floor bone resulting from the lesion. In cases with no obvious sellar floor bone destruction (e.g., suprasellar craniopharyngioma), the support plate is shaped into a slight "S" curve to ensure tight apposition to the dural window and the inlay artificial dura, preventing the formation of intervening gaps.
Placement: Since the support plate requires tight embedding under the anterior and posterior bone edges, bone edges at the tuberculum sellae and clivus should be preserved during sellar floor drilling according to surgical exposure and plate embedding requirements to facilitate secure fixation.
| Study group | Role | What they receive |
|---|---|---|
| Standard skull base reconstruction plus the absorbable and moldable skull base support plate | Experimental | The intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach :
Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification).
Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.).
Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer.
Trimming, shaping, and placement of the skull base support plate. Covering with mucosa: Cover the outer surface of the support plate with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge Receives: Device: Absorbable and moldable skull base support plate |
| Standard skull base reconstruction protocol | No intervention | No intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach : Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification). Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.). Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer. Cover with mucosa: Cover the outer surface of the dural layer with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cerebrospinal fluid (CSF) rhinorrhea
Confirmed by combining clinical symptoms, imaging examinations, and nasal endoscopy, including but not limited to the following indicators:
Clinical symptoms: persistent high fever (maximum temperature > 38.5 °C for more than 3 days), nausea and vomiting, decreased consciousness, positive meningeal irritation signs, etc.; Imaging examinations: CT or MRI showing fluid accumulation in the paranasal sinuses, intracranial pneumocephalus, etc.; Nasal endoscopy demonstrating persistent cerebrospinal fluid leakage from the sellar floor wound.
Measured: Within 1 month postoperatively
Secondary outcomes (1)
Incidence of intracranial infection
Clinical symptoms: persistent high fever (maximum temperature > 38.5 °C for more than 3 days), nausea and vomiting, decreased consciousness, positive meningeal irritation signs, etc.; Confirmed by pathogenic examination of cerebrospinal fluid via lumbar puncture.
Measured: Within 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sellar TumorStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Zhaoqing, Sun Yat-Sen University Cancer Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, The People's Hospital of Gaozhou, First People's Hospital of Foshan, Huizhou Municipal Central Hospital, LiuZhou People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539792
- Sponsor's protocol ID
- NFEC-2026-111
- Acronym
- EEEA-AMSBP
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07539792
- Acronym / sponsor ID
- EEEA-AMSBP / NFEC-2026-111
- Conditions
- Sellar Tumor, Endonasal Surgery, Csf Leakage
- Keywords
- Sellar Tumor, Extended Endoscopic Endonasal Transsphenoidal Surgery, Cerebrospinal Fluid Rhinorrhea, Skull Base Reconstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- First People's Hospital of Zhaoqing, Sun Yat-Sen University Cancer Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, The People's Hospital of Gaozhou, First People's Hospital of Foshan, Huizhou Municipal Central Hospital, LiuZhou People's Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 20 Apr 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.
Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery.
Secondary objectives:
- To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of intracranial infection within 1 months after surgery;
- To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the duration of the surgery and length of postoperative hospital stay;
- To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.
Detailed description
This is a multicenter, two-arm, open-label, randomized, controlled phase II clinical trial. It plans to enroll patients with sellar region tumors who will undergo extended endoscopic endonasal transsphenoidal approach. The aim is to compare the incidence of CSF rhinorrhea within 1 month after surgery between the combination of standard sellar floor repair + absorbable and moldable skull base support plate repair and the standard sellar floor repair group, and evaluate its safety and efficacy, so as to provide new strategies and basis for clinical treatment.
Statistical Analysis:
Analysis Sets:
Full Analysis Set (FAS), Per Protocol Set (PPS), and Safety Set (SS) will be used for statistical analysis.
- Full Analysis Set (FAS): Refers to the set of all subjects who have received the trial after enrollment and have undergone at least one efficacy assessment.
- Safety Set (SS):
Refers to the set of all subjects who have received the trial after enrollment and have undergone at least one safety indicator evaluation.
- Per Protocol Set (PPS): The set of cases in the Full Analysis Set that have completed the trial as specified in the protocol and have no serious violations of the trial protocol.
This is a phase II clinical trial. The sample size of this study will be calculated based on the hypothesis of a 1:1 parallel design sample rate in the two groups. The specific method is to compare the incidence of CSF rhinorrhea (CSF Leakage Rate, CLR) within 1 month after surgery in the experimental group (i.e., standard sellar floor repair + absorbable and moldable skull base support plate repair group) with that in the standard sellar floor repair group. It is assumed that the CLR in the experimental group is 1% (p1=0.01) and that in the standard sellar floor repair group is 15% (p2=0.15). The significance level is set at 0.025 (one-sided test), and the power is 80%. According to literature references and study design, we expect to recruit approximately 56 subjects in each group. Allowing for a 10% loss to follow-up, the sample size will be increased to N = 126 (63 subjects per group).
All statistical analyses will be performed using SAS 9.2 statistical analysis software.
Follow-up Face-to-face oral follow-up will be conducted for patients who return to the hospital for reexamination, and telephone follow-up will be conducted for patients who cannot return to the hospital for reexamination.
Statistical Methods
Data Processing:
Data processing and analysis will be performed using SAS 9.2 statistical analysis software. All continuous variables will be expressed as mean ± standard deviation (Mean ± SD) or median (interquartile range), and categorical variables will be expressed as frequency and percentage.
Analysis of Primary Efficacy Indicators:
Incidence of CSF rhinorrhea (CLR) within 1 month after surgery: Evaluated according to clinical symptoms, imaging, and nasal endoscopy standards. Chi-square test or Fisher's exact test will be used to analyze the CLR of each group.
Analysis of Secondary Efficacy Indicators:
- Incidence of intracranial infection within 1 month after surgery: Inter-group analysis will be performed using chi-square test or Fisher's exact test.
- Utilization rate of autologous fascia, fat, and nasal septum mucosal flaps: Inter-group analysis will be performed using chi-square test or Fisher's exact test.
- Length of duration of the surgery and postoperative hospital stay: Inter-group analysis will be performed using t-test or non-parametric test.
Safety Analysis:
Treatment-related adverse events will be evaluated according to the CTCAE 5.0 standard. The incidence of adverse events in each group will be analyzed using chi-square test or Fisher's exact test, and the frequency and severity of adverse events will be described by category.
Significance Level:
All statistical tests are two-sided tests, and the significance level is set at P < 0.05. P < 0.05 is considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard skull base reconstruction plus the absorbable and moldable skull base support plate | Experimental | Device: Absorbable and moldable skull base support plateThe intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach : Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification). Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.). Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer. Trimming, shaping, and placement of the skull base support plate. Covering with mucosa: Cover the outer surface of the support plate with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge |
| Standard skull base reconstruction protocol | No intervention | –No intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach : Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification). Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.). Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer. Cover with mucosa: Cover the outer surface of the dural layer with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 1-80 years, regardless of gender;
- Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;
- Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;
- Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;
- Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;
Key exclusion criteria (9 listed)
- Patients with other concurrent intracranial tumors or severe brain lesions;
- Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;
- Patients with uncontrolled severe heart, lung, kidney, or liver diseases;
- Pregnant or lactating women;
- Patients who have previously received radiotherapy or chemotherapy;
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 |
|---|---|---|
| Absorbable and moldable skull base support plateThe sbsorbable and moldable skull base support plate is used during the skull base repair phase of the surgery. Trimming: Measure the size of the skull base defect bone window (from the tuberculum sellae to the clival bone edge). Cut the malleable support plate slightly longer than this dimension. Shaping: Shape the plate according to the morphological changes of the sellar floor bone resulting from the lesion. In cases with no obvious sellar floor bone destruction (e.g., suprasellar craniopharyngioma), the support plate is shaped into a slight "S" curve to ensure tight apposition to the dural window and the inlay artificial dura, preventing the formation of intervening gaps. Placement: Since the support plate requires tight embedding under the anterior and posterior bone edges, bone edges at the tuberculum sellae and clivus should be preserved during sellar floor drilling according to surgical exposure and plate embedding requirements to facilitate secure fixation. | Device | Standard skull base reconstruction plus the absorbable and moldable skull base support plate |
Primary outcome
Incidence of cerebrospinal fluid (CSF) rhinorrhea
Time frame: Within 1 month postoperatively
Confirmed by combining clinical symptoms, imaging examinations, and nasal endoscopy, including but not limited to the following indicators: Clinical symptoms: persistent high fever (maximum temperature > 38.5 °C for more than 3 days), nausea and vomiting, decreased consciousness, positive meningeal irritation signs, etc.; Imaging examinations: CT or MRI showing fluid accumulation in the paranasal sinuses, intracranial pneumocephalus, etc.; Nasal endoscopy demonstrating persistent cerebrospinal fluid leakage from the sellar floor wound.
1 secondary outcome
Incidence of intracranial infection
Time frame: Within 1 month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Absorbable and moldable skull base support plate in people with Sellar Tumor and Endonasal Surgery, run by Nanfang Hospital, Southern Medical University at 8 sites in China.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pan MD, Ph.D (+86-13076878155, 1448875873@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cerebrospinal fluid (CSF) rhinorrhea (time frame: Within 1 month postoperatively). 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 20 Apr 2026.