Celiac DiseaseNCT03095573
Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease
A study testing Lateral-viewing CapsoCam device and Axial-viewing capsule in people with Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
Trial summary
Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Lateral-viewing CapsoCam device and Axial-viewing capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2017to 28 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with celiac disease at high risk of complication (see above for a detailed description)
Who cannot join
- presence of Pacemaker or Defibrillator
- suspected small bowel obstruction
- impaired swallowing
- pregnancy
- presence of contraindications to a capsule endoscopy examination
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Luca Elli, MD, PhD, +390255033384, lucelli@yahoo.com
Federica Branchi, MD
- Active, not recruiting
Irccs Policlinico San Donato
San Donato Milanese, MI, 20097
About this study
Official title: Prospective Randomized Comparison Between Axial- and Lateral-viewing Capsule Endoscopy Systems in Celiac Patients: a Pilot Study
Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune enteropathy in Western countries, and is usually associated with a good response to the gluten free diet and an excellent prognosis. However, a minority of patients develop complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically improved thank to the availability of capsule endoscopy exploration. The aim of this study was to evaluate detection rate and diagnostic concordance of the axial view capsule and CapsoCam capsules in the same patients.
Read the detailed description
The study will involve 25 patients with suspected complicated celiac disease , which for clinical reasons are referred for an evaluation of the small intestine by means of capsule endoscopic in order to screen/identify complications. Furthermore, patients under regular follow-up for a known complication of celiac disease (i.e. refractory celiac disease, ulcerative jejunoileitis) will also be enrolled.
Patients reffered to the Center for Prevention and Diagnosis of celiac disease at the research Hospital "Fondazione Cà Granda Ospedale Maggiore Policlinico" in Milan will be prospectively evaluated and consecutively enrolled in the study.
In agreement with international Guidelines, the diagnosis of celiac disease will be based on Presence of atrophy in the duodenal biopsy sampling (Marsh-Oberhuber type 3) and positive serology or genetic compatibility (in case of seronegative patients at diagnosis).
Patients at high risk of celiac disease complications are defined as
- subjects older than 50 years at the time of celiac disease diagnosis
- subjects with persistence / recurrence of gastrointestinal symptoms after at least 6 months of gluten-free diet
- subjects reporting poor compliance to the gluten-free diet
- subjects with alarm signs at diagnosis or during follow-up.
All enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another, according to a protocol already validated in terms of security in other studies. The order of administration of the two different capsules, will be determined by a specific randomization sequence.
At the end of the examination, recorded data from the capsules will be acquired according to the following steps:
- For the axial-view capsule: removal of the recorder after 10 hours recording and/or after checking that the capsule has reached the cecum. The patient will also be instructed to retrieve the capsule from the stools in the hours / days following the examination as per standard protocol.
- For the lateral-view capsule, the patient will be given a specific kit for its retrieval and conservation. The recorded data will be downloaded after retrieval of the capsule.
The 50 videos will be reviewed by three experts operators (L.E., F.B. G.E.T.), blinded and in randomized order. The operators will evaluate the number of lesions detected by the two different types of capsule system (Primary endpoint) and the mean extension of the lesions detected, expressed as percentage of the total transit time of the capsule in the small intestine (Secondary endpoint)
- Conditions
- Celiac Disease
- Being tested
- Lateral-viewing CapsoCam device, Axial-viewing capsule
- Keywords
- Celiac disease, Enteropathy associated T cell lymphoma, Refractory celiac disease, Small bowel adenocarcinoma
- Medical subject headings
- Celiac Disease, Enteropathy-Associated T-Cell Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral-viewing CapsoCam deviceDevice
Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device
Axial-viewing capsuleDevice
Small bowel capsule endoscopy examination with the Axial-viewing capsule device
| Study group | Role | What they receive |
|---|---|---|
| Lateral-viewing capsule | Experimental | Examination of the small bowel by means of the lateral-viewing CapsoCam device Receives: Device: Lateral-viewing CapsoCam device |
| Axial-viewing capsule | Active comparator | Examination of the small bowel by means of the axial-viewing capsule Receives: Device: Axial-viewing capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions detected
Mean number of lesions detected by the two different types of devices, expressed as diagnostic yield and total number of lesions
Measured: up to 24 hours, the time of progression of the capsule through the small bowel
Secondary outcomes (1)
Extension of the lesions
Mean extension of the lesions detected, expressed as percentage of the total transit time of the capsule in the small intestine
Measured: up to 24 hours, the time of progression of the capsule through the small bowel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Oct 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another. The order of administration of the two different capsules will be determined by a specific randomization sequence.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Responsible party
- Principal investigator, Luca Elli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Luca Elli, MD, PhD, Principal investigator, Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095573
- Sponsor's protocol ID
- Capsocam
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Volta U, Bellentani S, Bianchi FB, Brandi G, De Franceschi L, Miglioli L, Granito A, Balli F, Tiribelli C. High prevalence of celiac disease in Italian general population. Dig Dis Sci. 2001 Jul;46(7):1500-5. doi: 10.1023/a:1010648122797.
PubMed 11478502Green PH, Fleischauer AT, Bhagat G, Goyal R, Jabri B, Neugut AI. Risk of malignancy in patients with celiac disease. Am J Med. 2003 Aug 15;115(3):191-5. doi: 10.1016/s0002-9343(03)00302-4.
PubMed 12935825Catassi C, Bearzi I, Holmes GK. Association of celiac disease and intestinal lymphomas and other cancers. Gastroenterology. 2005 Apr;128(4 Suppl 1):S79-86. doi: 10.1053/j.gastro.2005.02.027.
PubMed 15825131Culliford A, Daly J, Diamond B, Rubin M, Green PH. The value of wireless capsule endoscopy in patients with complicated celiac disease. Gastrointest Endosc. 2005 Jul;62(1):55-61. doi: 10.1016/s0016-5107(05)01566-x.
PubMed 15990820Daum S, Wahnschaffe U, Glasenapp R, Borchert M, Ullrich R, Zeitz M, Faiss S. Capsule endoscopy in refractory celiac disease. Endoscopy. 2007 May;39(5):455-8. doi: 10.1055/s-2007-966239.
PubMed 17516353Rondonotti E, Spada C, Cave D, Pennazio M, Riccioni ME, De Vitis I, Schneider D, Sprujevnik T, Villa F, Langelier J, Arrigoni A, Costamagna G, de Franchis R. Video capsule enteroscopy in the diagnosis of celiac disease: a multicenter study. Am J Gastroenterol. 2007 Aug;102(8):1624-31. doi: 10.1111/j.1572-0241.2007.01238.x. Epub 2007 Apr 24.
PubMed 17459022Rostom A, Murray JA, Kagnoff MF. American Gastroenterological Association (AGA) Institute technical review on the diagnosis and management of celiac disease. Gastroenterology. 2006 Dec;131(6):1981-2002. doi: 10.1053/j.gastro.2006.10.004. No abstract available.
PubMed 17087937Rondonotti E, Soncini M, Girelli C, Ballardini G, Bianchi G, Brunati S, Centenara L, Cesari P, Cortelezzi C, Curioni S, Gozzini C, Gullotta R, Lazzaroni M, Maino M, Mandelli G, Mantovani N, Morandi E, Pansoni C, Piubello W, Putignano R, Schalling R, Tatarella M, Villa F, Vitagliano P, Russo A, Conte D, Masci E, de Franchis R; AIGO, SIED and SIGE Lombardia. Small bowel capsule endoscopy in clinical practice: a multicenter 7-year survey. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1380-6. doi: 10.1097/MEG.0b013e3283352ced.
PubMed 20173646Bardella MT, Elli L, De Matteis S, Floriani I, Torri V, Piodi L. Autoimmune disorders in patients affected by celiac sprue and inflammatory bowel disease. Ann Med. 2009;41(2):139-43. doi: 10.1080/07853890802378817.
PubMed 18777226Leighton JA. The role of endoscopic imaging of the small bowel in clinical practice. Am J Gastroenterol. 2011 Jan;106(1):27-36; quiz 37. doi: 10.1038/ajg.2010.410. Epub 2010 Oct 26.
PubMed 20978483Pioche M, Vanbiervliet G, Jacob P, Duburque C, Gincul R, Filoche B, Daudet J, Filippi J, Saurin JC; French Society of Digestive Endoscopy (SFED). Prospective randomized comparison between axial- and lateral-viewing capsule endoscopy systems in patients with obscure digestive bleeding. Endoscopy. 2014 Jun;46(6):479-84. doi: 10.1055/s-0033-1358832. Epub 2013 Nov 27.
PubMed 24285122
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison Between Axial- and Lateral-viewing Capsule Endoscopy Systems in Celiac Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT03095573
- Acronym / sponsor ID
- Capsocam
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Enteropathy associated T cell lymphoma, Refractory celiac disease, Small bowel adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune enteropathy in Western countries, and is usually associated with a good response to the gluten free diet and an excellent prognosis. However, a minority of patients develop complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically improved thank to the availability of capsule endoscopy exploration. The aim of this study was to evaluate detection rate and diagnostic concordance of the axial view capsule and CapsoCam capsules in the same patients.
Detailed description
The study will involve 25 patients with suspected complicated celiac disease , which for clinical reasons are referred for an evaluation of the small intestine by means of capsule endoscopic in order to screen/identify complications. Furthermore, patients under regular follow-up for a known complication of celiac disease (i.e. refractory celiac disease, ulcerative jejunoileitis) will also be enrolled.
Patients reffered to the Center for Prevention and Diagnosis of celiac disease at the research Hospital "Fondazione Cà Granda Ospedale Maggiore Policlinico" in Milan will be prospectively evaluated and consecutively enrolled in the study.
In agreement with international Guidelines, the diagnosis of celiac disease will be based on Presence of atrophy in the duodenal biopsy sampling (Marsh-Oberhuber type 3) and positive serology or genetic compatibility (in case of seronegative patients at diagnosis).
Patients at high risk of celiac disease complications are defined as
- subjects older than 50 years at the time of celiac disease diagnosis
- subjects with persistence / recurrence of gastrointestinal symptoms after at least 6 months of gluten-free diet
- subjects reporting poor compliance to the gluten-free diet
- subjects with alarm signs at diagnosis or during follow-up.
All enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another, according to a protocol already validated in terms of security in other studies. The order of administration of the two different capsules, will be determined by a specific randomization sequence.
At the end of the examination, recorded data from the capsules will be acquired according to the following steps:
- For the axial-view capsule: removal of the recorder after 10 hours recording and/or after checking that the capsule has reached the cecum. The patient will also be instructed to retrieve the capsule from the stools in the hours / days following the examination as per standard protocol.
- For the lateral-view capsule, the patient will be given a specific kit for its retrieval and conservation. The recorded data will be downloaded after retrieval of the capsule.
The 50 videos will be reviewed by three experts operators (L.E., F.B. G.E.T.), blinded and in randomized order. The operators will evaluate the number of lesions detected by the two different types of capsule system (Primary endpoint) and the mean extension of the lesions detected, expressed as percentage of the total transit time of the capsule in the small intestine (Secondary endpoint)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another. The order of administration of the two different capsules will be determined by a specific randomization sequence.
| Arm | Type | Receives |
|---|---|---|
| Lateral-viewing capsule | Experimental | Device: Lateral-viewing CapsoCam deviceExamination of the small bowel by means of the lateral-viewing CapsoCam device |
| Axial-viewing capsule | Active comparator | Device: Axial-viewing capsuleExamination of the small bowel by means of the axial-viewing capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with celiac disease at high risk of complication (see above for a detailed description)
Key exclusion criteria (5 listed)
- presence of Pacemaker or Defibrillator
- suspected small bowel obstruction
- impaired swallowing
- pregnancy
- presence of contraindications to a capsule endoscopy examination
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 |
|---|---|---|
| Lateral-viewing CapsoCam deviceSmall bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device | Device | Lateral-viewing capsule |
| Axial-viewing capsuleSmall bowel capsule endoscopy examination with the Axial-viewing capsule device | Device | Axial-viewing capsule |
Primary outcome
Lesions detected
Time frame: up to 24 hours, the time of progression of the capsule through the small bowel
Mean number of lesions detected by the two different types of devices, expressed as diagnostic yield and total number of lesions
1 secondary outcome
Extension of the lesions
Time frame: up to 24 hours, the time of progression of the capsule through the small bowel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Background: PubMed 11478502Volta U, Bellentani S, Bianchi FB, Brandi G, De Franceschi L, Miglioli L, Granito A, Balli F, Tiribelli C. High prevalence of celiac disease in Italian general population. Dig Dis Sci. 2001 Jul;46(7):1500-5. doi: 10.1023/a:1010648122797.
- Background: PubMed 12935825Green PH, Fleischauer AT, Bhagat G, Goyal R, Jabri B, Neugut AI. Risk of malignancy in patients with celiac disease. Am J Med. 2003 Aug 15;115(3):191-5. doi: 10.1016/s0002-9343(03)00302-4.
- Background: PubMed 15825131Catassi C, Bearzi I, Holmes GK. Association of celiac disease and intestinal lymphomas and other cancers. Gastroenterology. 2005 Apr;128(4 Suppl 1):S79-86. doi: 10.1053/j.gastro.2005.02.027.
- Background: PubMed 15990820Culliford A, Daly J, Diamond B, Rubin M, Green PH. The value of wireless capsule endoscopy in patients with complicated celiac disease. Gastrointest Endosc. 2005 Jul;62(1):55-61. doi: 10.1016/s0016-5107(05)01566-x.
- Background: PubMed 17516353Daum S, Wahnschaffe U, Glasenapp R, Borchert M, Ullrich R, Zeitz M, Faiss S. Capsule endoscopy in refractory celiac disease. Endoscopy. 2007 May;39(5):455-8. doi: 10.1055/s-2007-966239.
- Background: PubMed 17459022Rondonotti E, Spada C, Cave D, Pennazio M, Riccioni ME, De Vitis I, Schneider D, Sprujevnik T, Villa F, Langelier J, Arrigoni A, Costamagna G, de Franchis R. Video capsule enteroscopy in the diagnosis of celiac disease: a multicenter study. Am J Gastroenterol. 2007 Aug;102(8):1624-31. doi: 10.1111/j.1572-0241.2007.01238.x. Epub 2007 Apr 24.
- Background: PubMed 17087937Rostom A, Murray JA, Kagnoff MF. American Gastroenterological Association (AGA) Institute technical review on the diagnosis and management of celiac disease. Gastroenterology. 2006 Dec;131(6):1981-2002. doi: 10.1053/j.gastro.2006.10.004. No abstract available.
- Background: PubMed 20173646Rondonotti E, Soncini M, Girelli C, Ballardini G, Bianchi G, Brunati S, Centenara L, Cesari P, Cortelezzi C, Curioni S, Gozzini C, Gullotta R, Lazzaroni M, Maino M, Mandelli G, Mantovani N, Morandi E, Pansoni C, Piubello W, Putignano R, Schalling R, Tatarella M, Villa F, Vitagliano P, Russo A, Conte D, Masci E, de Franchis R; AIGO, SIED and SIGE Lombardia. Small bowel capsule endoscopy in clinical practice: a multicenter 7-year survey. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1380-6. doi: 10.1097/MEG.0b013e3283352ced.
- Background: PubMed 18777226Bardella MT, Elli L, De Matteis S, Floriani I, Torri V, Piodi L. Autoimmune disorders in patients affected by celiac sprue and inflammatory bowel disease. Ann Med. 2009;41(2):139-43. doi: 10.1080/07853890802378817.
- Background: PubMed 20978483Leighton JA. The role of endoscopic imaging of the small bowel in clinical practice. Am J Gastroenterol. 2011 Jan;106(1):27-36; quiz 37. doi: 10.1038/ajg.2010.410. Epub 2010 Oct 26.
- Background: PubMed 24285122Pioche M, Vanbiervliet G, Jacob P, Duburque C, Gincul R, Filoche B, Daudet J, Filippi J, Saurin JC; French Society of Digestive Endoscopy (SFED). Prospective randomized comparison between axial- and lateral-viewing capsule endoscopy systems in patients with obscure digestive bleeding. Endoscopy. 2014 Jun;46(6):479-84. doi: 10.1055/s-0033-1358832. Epub 2013 Nov 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Elli, MD, PhD principal investigator
Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral-viewing CapsoCam device and Axial-viewing capsule in people with Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Elli, MD, PhD (+390255033384, lucelli@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesions detected (time frame: up to 24 hours, the time of progression of the capsule through the small bowel). 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 NCT03095573, which also lists 11 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 30 Mar 2017; AzTrials last refreshed its copy on 26 Oct 2026.