Hiatal Hernia With Gastroesophageal Reflux DiseaseNCT07387042
Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation
A study testing Laparoscopic Hill-Snow repair and Laparoscopic Nissen Fundoplication in people with Hiatal Hernia With Gastroesophageal Reflux Disease, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the clinical efficacy and safety of laparoscopic Nissen fundoplication (LNF) versus laparoscopic Hill-Snow repair (LHS) in the management of patients with congenital hiatus hernia, to evaluate the role of upper gastrointestinal endoscopy in the preoperative diagnosis and… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hiatal Hernia With Gastroesophageal Reflux Disease
- What is being tested?
- Laparoscopic Hill-Snow repair and Laparoscopic Nissen Fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2026to Oct 2027
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged less than 18 years including both sexes with a confirmed diagnosis of congenital hiatus hernia
- Diagnosis of hiatus hernia refractory to maximal medical therapy (PPI for ≥12 weeks) AND/OR presence of complications (e.g., erosive esophagitis, Barrett's esophagus, recurrent aspiration pneumonia, failure to thrive)
- Objective evidence of pathological GERD on upper endoscopy e.g: erosive esophagitis, Barrett's esophagus.
Who cannot join
- Previous esophageal or gastric surgery
- Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Pediatrics and Pediatric Surgery University Hospital, Faculty Of Medicine, Minia Universty
Minya
Mohamed F Abdelrahman, +20 10 06350884, drfathym@yahoo.com
About this study
Official title: Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation: Randomized Controlled Trial
The goal of this clinical trial is to compare the clinical efficacy and safety of laparoscopic Nissen fundoplication (LNF) versus laparoscopic Hill-Snow repair (LHS) in the management of patients with congenital hiatus hernia, to evaluate the role of upper gastrointestinal endoscopy in the preoperative diagnosis and planning \& to determine the utility of intraoperative endoscopy in guiding the surgical repair and ensuring its technical adequacy.
main questions are:
- which one of these techniques is safer with higher clinical efficacy represented by relief of GERD symptoms ?
- does upper GI endoscopy have a role in preoperative stage regarding diagnosis of condition and planning of treatment ?
- does upper GI endoscopy have a role in intraoperative stage regarding guiding the surgical repair and ensuring its adequacy ? all participants will be randomly assigned in one of two groups:
- one group undergoing Laparoscopic Nissen Fundoplication
- the other group undergoing Laparoscopic Hill-Snow repair each participsant will have preopertive, intraoperative and postoperative upper GI endoscopy to assess objectively clinical efficacy of both techniques and to define the integral role of endoscopy in all three perioperative stages
Read the detailed description
Congenital hiatus hernia (CHH), though less common than acquired forms, presents a significant clinical challenge, particularly in the pediatric and young adult populations. It is characterized by a congenital defect in the phrenoesophageal membrane, allowing for herniation of gastric cardia into the mediastinum. This anatomical disruption compromises the lower esophageal sphincter (LES) mechanism, leading to severe gastroesophageal reflux disease (GERD), which can result in failure to thrive, esophagitis, recurrent aspiration pneumonia, and long-term sequelae like Barrett's esophagus.
When medical management fails or in cases of significant complications, surgical intervention is imperative. The goals of surgery are the anatomical reduction of the hernia, reconstruction of the esophagogastric junction (EGJ), and restoration of an effective anti-reflux barrier. Laparoscopic repair has become the gold standard due to its benefits of reduced postoperative pain, shorter hospital stay, and better cosmesis.
Two prominent laparoscopic techniques are:
Laparoscopic Nissen Fundoplication (LNF): A 360-degree wrap is the most common anti-reflux procedure worldwide. It is highly effective in controlling reflux but is associated with potential side effects like gas-bloat syndrome, dysphagia, and inability to belch.
Laparoscopic Hill-Snow Repair (LHS): This technique focuses on a precise anatomical restoration of the EGJ by anchoring it to the median arcuate ligament of the diaphragm. It aims to recreate the valvular mechanism without a complete wrap, potentially reducing the typical side effects of Nissen fundoplication.
Endoscopy plays a crucial but often under-standardized role in the perioperative management of CHH.
Preoperatively, it is essential for diagnosing esophagitis, Barrett's metaplasia, and ruling out other pathologies. It also helps in assessing the size and reducibility of the hernia.
Intraoperatively, endoscopy (laparoscopic-endoscopic collaboration) can guide the surgeon in assessing the tightness of the fundoplication, identifying the Z-line for accurate placement of the wrap, and ensuring no mucosal perforation has occurred.
Postoperatively, endoscopy is the primary tool for evaluating anatomical success, detecting recurrence, and managing persistent symptoms like dysphagia.
While numerous studies have compared various fundoplication techniques for GERD, there is a paucity of literature directly comparing LNF and LHS specifically in the context of congenital hiatus hernia. Furthermore, a systematic protocol defining the integral role of endoscopy in all three perioperative stages is lacking. This study aims to fill this gap by providing a comparative analysis of the functional outcomes and complications of these two techniques and by establishing a standardized perioperative endoscopic protocol.
- Being tested
- Laparoscopic Hill-Snow repair, Laparoscopic Nissen Fundoplication
- Keywords
- Hiatus Hernia, Nissen Fundoplication, Hill-Snow repair, Endoscopy
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Hill-Snow repairProcedure or surgery
a laparoscopic surgical operation to fix severe acid reflux (GERD) and hiatal hernias by restoring the natural anti-reflux mechanism,acting as an alternative to the more common Nissen fundoplication, It's known for firmly anchoring the stomach to reliable structures, creating a flap valve, and reducing recurrence
What it does
- Reduces hiatal hernia: Pulls down the stomach that has slipped into the chest.
- Recreates valve: Re-establishes the angle of His (the valve between the esophagus and stomach).
- Secures the junction: Sews the lower esophagus and stomach to the diaphragm and abdominal structures, preventing reflux
How it works (basic steps)
Dissect: Free the esophagus and pull down the herniated stomach. Repair hernia: Close the opening (hiatus) in the diaphragm (cruroplasty). Fix stomach: Sew the stomach (fundus) to the esophagus and diaphragm (gastropexy).
Create angle: Recreate the angle of His with sutures
Laparoscopic Nissen FundoplicationProcedure or surgery
a minimally invasive keyhole surgery that treats severe acid reflux (GERD) by wrapping the upper part of the stomach (fundus) around the lower esophagus to create a stronger valve, preventing stomach acid from traveling up. Performed through small incisions, it's a more permanent solution than medication, often used when lifestyle changes and drugs fail, and involves a quicker recovery than traditional open surgery.
How it works Reinforces the valve: The stomach's fundus is wrapped around the esophagus, strengthening the natural anti-reflux barrier.
Stops acid flow: This "wrap" stops stomach acid and enzymes from splashing back into the esophagus.
Corrects hiatal hernia: If present, a hiatal hernia (when part of the stomach pushes through the diaphragm) is also repaired during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Hill-Snow repair | Experimental | Not described Receives: Procedure: Laparoscopic Hill-Snow repair |
| Laparoscopic Nissen Fundoplication | Active comparator | Not described Receives: Procedure: Laparoscopic Nissen Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of relief of GERD symptoms assessed by GERD Health-Related Quality Of Life (GERD-HRQL) score
The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Total Score: Calculated by summing the individual scores to 15 questions * Greatest possible score (worst symptoms) = 75 * Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to 6 questions * Worst heartburn symptoms = 30 * No heartburn symptoms = 0 * Scores less than or equal to 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to 6 questions . *Worst regurgitation symptoms = 30 * No regurgitation = 0 * Scores less than or equal to 12 with each individual question not exceeding 2 indicate regurgitation.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hiatal Hernia With Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassaan Hamdy, Minia University
- Investigators
- Alaa A El sayed, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387042
- Sponsor's protocol ID
- 1799/11/2025
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
PubMed 29437910Mönig, S. P., & Hölscher, A. H. (2006). Intraoperative endoscopy. Langenbeck's Archives of Surgery, 391(2), 99-104.
Spechler, S. J., & Hunter, J. G. (2017). A Modern View of Hiatal Hernia: Lessons from Surgical and Gastroenterologic Literature. Gastroenterology, 153(4), 911-914.
Hill, L. D., & Snow, L. L. (1999). The Hill-Snow repair for gastroesophageal reflux disease. Surgical Clinics of North America.
NISSEN R. [A simple operation for control of reflux esophagitis]. Schweiz Med Wochenschr. 1956 May 18;86(Suppl 20):590-2. No abstract available. German.
PubMed 13337262Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010 Nov;24(11):2647-69. doi: 10.1007/s00464-010-1267-8. Epub 2010 Aug 20. No abstract available.
PubMed 20725747Hyun, J. J., & Bak, Y. T. (2011). Clinical Significance of Hiatal Hernia. The Korean Journal of Gastroenterology, 57(3), 160-165.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07387042
- Acronym / sponsor ID
- 1799/11/2025
- Keywords
- Hiatus Hernia, Nissen Fundoplication, Hill-Snow repair, Endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Feb 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.
The goal of this clinical trial is to compare the clinical efficacy and safety of laparoscopic Nissen fundoplication (LNF) versus laparoscopic Hill-Snow repair (LHS) in the management of patients with congenital hiatus hernia, to evaluate the role of upper gastrointestinal endoscopy in the preoperative diagnosis and planning \& to determine the utility of intraoperative endoscopy in guiding the surgical repair and ensuring its technical adequacy.
main questions are:
- which one of these techniques is safer with higher clinical efficacy represented by relief of GERD symptoms ?
- does upper GI endoscopy have a role in preoperative stage regarding diagnosis of condition and planning of treatment ?
- does upper GI endoscopy have a role in intraoperative stage regarding guiding the surgical repair and ensuring its adequacy ? all participants will be randomly assigned in one of two groups:
- one group undergoing Laparoscopic Nissen Fundoplication
- the other group undergoing Laparoscopic Hill-Snow repair each participsant will have preopertive, intraoperative and postoperative upper GI endoscopy to assess objectively clinical efficacy of both techniques and to define the integral role of endoscopy in all three perioperative stages
Detailed description
Congenital hiatus hernia (CHH), though less common than acquired forms, presents a significant clinical challenge, particularly in the pediatric and young adult populations. It is characterized by a congenital defect in the phrenoesophageal membrane, allowing for herniation of gastric cardia into the mediastinum. This anatomical disruption compromises the lower esophageal sphincter (LES) mechanism, leading to severe gastroesophageal reflux disease (GERD), which can result in failure to thrive, esophagitis, recurrent aspiration pneumonia, and long-term sequelae like Barrett's esophagus.
When medical management fails or in cases of significant complications, surgical intervention is imperative. The goals of surgery are the anatomical reduction of the hernia, reconstruction of the esophagogastric junction (EGJ), and restoration of an effective anti-reflux barrier. Laparoscopic repair has become the gold standard due to its benefits of reduced postoperative pain, shorter hospital stay, and better cosmesis.
Two prominent laparoscopic techniques are:
Laparoscopic Nissen Fundoplication (LNF): A 360-degree wrap is the most common anti-reflux procedure worldwide. It is highly effective in controlling reflux but is associated with potential side effects like gas-bloat syndrome, dysphagia, and inability to belch.
Laparoscopic Hill-Snow Repair (LHS): This technique focuses on a precise anatomical restoration of the EGJ by anchoring it to the median arcuate ligament of the diaphragm. It aims to recreate the valvular mechanism without a complete wrap, potentially reducing the typical side effects of Nissen fundoplication.
Endoscopy plays a crucial but often under-standardized role in the perioperative management of CHH.
Preoperatively, it is essential for diagnosing esophagitis, Barrett's metaplasia, and ruling out other pathologies. It also helps in assessing the size and reducibility of the hernia.
Intraoperatively, endoscopy (laparoscopic-endoscopic collaboration) can guide the surgeon in assessing the tightness of the fundoplication, identifying the Z-line for accurate placement of the wrap, and ensuring no mucosal perforation has occurred.
Postoperatively, endoscopy is the primary tool for evaluating anatomical success, detecting recurrence, and managing persistent symptoms like dysphagia.
While numerous studies have compared various fundoplication techniques for GERD, there is a paucity of literature directly comparing LNF and LHS specifically in the context of congenital hiatus hernia. Furthermore, a systematic protocol defining the integral role of endoscopy in all three perioperative stages is lacking. This study aims to fill this gap by providing a comparative analysis of the functional outcomes and complications of these two techniques and by establishing a standardized perioperative endoscopic protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Hill-Snow repair | Experimental | Procedure: Laparoscopic Hill-Snow repair |
| Laparoscopic Nissen Fundoplication | Active comparator | Procedure: Laparoscopic Nissen Fundoplication |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged less than 18 years including both sexes with a confirmed diagnosis of congenital hiatus hernia
- Diagnosis of hiatus hernia refractory to maximal medical therapy (PPI for ≥12 weeks) AND/OR presence of complications (e.g., erosive esophagitis, Barrett's esophagus, recurrent aspiration pneumonia, failure to thrive)
- Objective evidence of pathological GERD on upper endoscopy e.g: erosive esophagitis, Barrett's esophagus.
Key exclusion criteria (2 listed)
- Previous esophageal or gastric surgery
- Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.
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 |
|---|---|---|
| Laparoscopic Hill-Snow repaira laparoscopic surgical operation to fix severe acid reflux (GERD) and hiatal hernias by restoring the natural anti-reflux mechanism,acting as an alternative to the more common Nissen fundoplication, It's known for firmly anchoring the stomach to reliable structures, creating a flap valve, and reducing recurrence What it does * Reduces hiatal hernia: Pulls down the stomach that has slipped into the chest. * Recreates valve: Re-establishes the angle of His (the valve between the esophagus and stomach). * Secures the junction: Sews the lower esophagus and stomach to the diaphragm and abdominal structures, preventing reflux How it works (basic steps) Dissect: Free the esophagus and pull down the herniated stomach. Repair hernia: Close the opening (hiatus) in the diaphragm (cruroplasty). Fix stomach: Sew the stomach (fundus) to the esophagus and diaphragm (gastropexy). Create angle: Recreate the angle of His with sutures | Procedure or surgery | Laparoscopic Hill-Snow repair |
| Laparoscopic Nissen Fundoplicationa minimally invasive keyhole surgery that treats severe acid reflux (GERD) by wrapping the upper part of the stomach (fundus) around the lower esophagus to create a stronger valve, preventing stomach acid from traveling up. Performed through small incisions, it's a more permanent solution than medication, often used when lifestyle changes and drugs fail, and involves a quicker recovery than traditional open surgery. How it works Reinforces the valve: The stomach's fundus is wrapped around the esophagus, strengthening the natural anti-reflux barrier. Stops acid flow: This "wrap" stops stomach acid and enzymes from splashing back into the esophagus. Corrects hiatal hernia: If present, a hiatal hernia (when part of the stomach pushes through the diaphragm) is also repaired during the procedure. | Procedure or surgery | Laparoscopic Nissen Fundoplication |
Primary outcome
Degree of relief of GERD symptoms assessed by GERD Health-Related Quality Of Life (GERD-HRQL) score
Time frame: 6 months postoperatively
The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Total Score: Calculated by summing the individual scores to 15 questions * Greatest possible score (worst symptoms) = 75 * Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to 6 questions * Worst heartburn symptoms = 30 * No heartburn symptoms = 0 * Scores less than or equal to 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to 6 questions . *Worst regurgitation symptoms = 30 * No regurgitation = 0 * Scores less than or equal to 12 with each individual question not exceeding 2 indicate regurgitation.
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 4 Feb 2026.
- Background: PubMed 29437910Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
- BackgroundMönig, S. P., & Hölscher, A. H. (2006). Intraoperative endoscopy. Langenbeck's Archives of Surgery, 391(2), 99-104.
- BackgroundSpechler, S. J., & Hunter, J. G. (2017). A Modern View of Hiatal Hernia: Lessons from Surgical and Gastroenterologic Literature. Gastroenterology, 153(4), 911-914.
- BackgroundHill, L. D., & Snow, L. L. (1999). The Hill-Snow repair for gastroesophageal reflux disease. Surgical Clinics of North America.
- Background: PubMed 13337262NISSEN R. [A simple operation for control of reflux esophagitis]. Schweiz Med Wochenschr. 1956 May 18;86(Suppl 20):590-2. No abstract available. German.
- Background: PubMed 20725747Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010 Nov;24(11):2647-69. doi: 10.1007/s00464-010-1267-8. Epub 2010 Aug 20. No abstract available.
- BackgroundHyun, J. J., & Bak, Y. T. (2011). Clinical Significance of Hiatal Hernia. The Korean Journal of Gastroenterology, 57(3), 160-165.
- 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.
Alaa A El sayed principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Hill-Snow repair and Laparoscopic Nissen Fundoplication in people with Hiatal Hernia With Gastroesophageal Reflux Disease, run by Minia University at 1 site in Egypt.
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 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: opening soon, as of the sponsor's last update on 4 Feb 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 Egypt. 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?
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 Mohamed H Hamdy, Master (+201064771480, mhh_raheel92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of relief of GERD symptoms assessed by GERD Health-Related Quality Of Life (GERD-HRQL) score (time frame: 6 months postoperatively). 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 NCT07387042, which also lists 7 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 4 Feb 2026.