Morbid ObesityNCT01998243
Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity
A study testing Intragastric Balloon (IGB), group A in people with Morbid Obesity, run by Hospital Severo Ochoa at 1 site in Spain.
Trial summary
Introduction: bariatric surgery shows an important morbidity and there are some reports that have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Intragastric Balloon (IGB), group A
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Morbid obesity (BMI ≥ 40 kg/m2 ) with a failed Conventional Medical treatment
- - Morbid obesity (BMI ≥ 35 kg/m2) with important comorbidity with a failed Conventional Medical treatment
- - they should be operated by a laparoscopic gastric sleeve or by laparoscopic gastric by-pass
Who cannot join
- - Slight adherence to previous medical treatments .
- - Hiatal hernia more than 3 cms
- - Patients with active gastric or duodenal ulcer disease
- - Severe esophagitis
- - Psychiatric diseases (depression, bulimia etc)
- - Associated Severe Systemic Disease not amenable to improve with weight loss
Show all 14Show fewer
- - Patients with Inflammatory bowel diseases
- - Patients on anticoagulant treatment or steroids .
- - Addiction to Drugs or alcohol
- - Past history of gastric surgery ,antireflux surgery or any other type of bariatric surgery
- - Patient refusing to be followed 6 months before and after surgery
- - Pregnancy or foreseeable pregnancy during the study
- - Patients with gastric or esophageal varices
- - proton pump inhibitor (PPI) allergy
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gastroenterology Department ,Severo Ochoa Hospital
Leganés, Madrid, 28911
About this study
Official title: Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity
Introduction: bariatric surgery shows an important morbidity and there are some reports that have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity.
Patients Methods: Since 2009 we are performing a randomized and prospective study to assess the usefulness of (IGB-BIB®) before bariatric surgery [sleeve resection (SR) or gastric bypass (GB)] "group A". The intervention in this group was was to place an intragastric Balloon for 6 months vs a control group "B" with the same type of surgical procedures but without preoperative IGB-BIB.The intervention on this group was only to treat the obesity only with diet for 6 months . All patients coming for both groups were followed at 4-week intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least 30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery was associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB failure.Intragastric balloon failure was considered when the weight loss is less than 10% from the initial weight. We defined severe complication whenever the patient had to be admitted in the hospital after discharge, new surgeries or transfusions were required or the hospital stay was longer than 7-10 days.
Read the detailed description
Treatment with an intragastric balloon (IGB) for morbid obesity is a temporary treatment reached as a second step, when the initial nutritional multidisciplinary approach has failed; however, its value is not clear compared with other conventional medical treatments ], though some authors have stated that IGB achieves higher weight loss than conventional diet treatments (12.2% of the initial weight) ]; and others have positioned IGB as the first valid step in order to achieve weight loss in patients who are adequate for a future gastric bypass surgery. Genco et al (2009) have compared the treatment with IGB only vs. laparoscopic sleeve gastrectomy (LSG), and have found no differences in the amount of weight loss at 6 months, but a reduction in adverse events caused by IGB treatment.
One of the potential future indications for the intragastric balloon could be its use as a bridge-treatment until bariatric surgery, not only in order to achieve weight loss before surgery, but also to select the group of patients who might benefit more from derivative surgery, as suggested by some authors or its use in special populations such as super-obese patients . The objective would be to reduce weight before the surgical procedure, in order to improve comorbidities, facilitate the surgical technique, and potentially reduce any surgical complications.
It is increasingly frequent in many surgical units to try and achieve weigh loss before bariatric surgery, using intragastric balloons (IGB). However, this therapeutic approach currently presents dubious utility. Our study intends to contribute with our experience in the evaluation of IGB before surgery for achieving weight loss, and its impact on post-surgical morbidity.
Bariatric surgery shows an important morbidity and there are not to many randomized prospective studies using intragastric- balloons (IGB-BIB®) to evaluate if getting weight lost really matter on decreasing surgical complications before Bariatric surgery OBJECTIVE: To study the usefulness of preoperative IGB-BIB® "grA" [sleeve resection (SR) or gastric bypass (GB)] to help decrease postsurgical complications. Secondly we try to check the rate of IGB-BIB® failures (a total weight loss less than 10% of the initial weight), and the impact on decreasing hospital stay and rate of surgical reoperations. METHODS: The study was a clinical prospective and randomized essay coming from 2009. Cases (grA) had an IGB during 6 months before surgery vs Controls (grB)
- Conditions
- Morbid Obesity
- Being tested
- Intragastric Balloon (IGB), group A, diet, control group B
- Keywords
- morbid obesity, bioenterics intragastric balloon, bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragastric Balloon (IGB), group ADevice
Also called BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM
the intervention was to place An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM) endoscopically under conscious sedation and was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors (PPI), and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
diet, control group BOther
Also called 1200 Kilocalories (Kcal) diet
the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet
| Study group | Role | What they receive |
|---|---|---|
| IGB group A | Experimental | the intervention in the group A : was to place a preoperative intragastric balloon (IGB-BIB®) in the stomach for 6 months before surgery plus an hypocaloric diet 1200 Kilocalories (Kcal) Receives: Device: Intragastric Balloon (IGB), group A; Other: diet, control group B |
| control group B | Placebo comparator | the intervention in this control group B was the specified diet (a hypocaloric diet of 1200 Kilocalories (Kcal) Receives: Other: diet, control group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postsurgical Morbidity on Both Arms of the Study
postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
Measured: within the 90 days after surgery
Total Postsurgical Morbidity
total postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of "The accordion severity grading system ".
Measured: during the 6 months having the intragastric balloon and 90 days after surgery
Secondary outcomes (3)
Hospital Stay,
all in all hospital stay
Measured: the period of the study started when patients were randomizated and finished 90 days after surgery
Rate of Surgical Conversion to Open Surgery
number of patients with surgical conversion from laparoscopic to open surgery
Measured: during the initial laparoscopic surgery
Percentage of Re-operations
Percentage of Re-operations during all the period of the study ending within 90 days after surgery
Measured: during all the period of the study ending within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJan 2009
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Severo Ochoa
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, luis ramon rábago torre, Hospital Severo Ochoa
- Investigators
- Luis R Rábago, MD,PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998243
- Sponsor's protocol ID
- fis PI070682
- Other IDs
- FIS PI070682
- Status last verified
- Mar 2019
- First submitted
- 19 Nov 2013
- Last updated
- 10 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hodson RM, Zacharoulis D, Goutzamani E, Slee P, Wood S, Wedgwood KR. Management of obesity with the new intragastric balloon. Obes Surg. 2001 Jun;11(3):327-9. doi: 10.1381/096089201321336692.
PubMed 11433910Loffredo A, Cappuccio M, De Luca M, de Werra C, Galloro G, Naddeo M, Forestieri P. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001 Jun;11(3):330-3. doi: 10.1381/096089201321336700.
PubMed 11433911Doldi SB, Micheletto G, Perrini MN, Librenti MC, Rella S. Treatment of morbid obesity with intragastric balloon in association with diet. Obes Surg. 2002 Aug;12(4):583-7. doi: 10.1381/096089202762252398.
PubMed 12194556Busetto L, Segato G, De Luca M, Bortolozzi E, MacCari T, Magon A, Inelmen EM, Favretti F, Enzi G. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg. 2004 May;14(5):671-6. doi: 10.1381/096089204323093471.
PubMed 15186637Sallet JA, Marchesini JB, Paiva DS, Komoto K, Pizani CE, Ribeiro ML, Miguel P, Ferraz AM, Sallet PC. Brazilian multicenter study of the intragastric balloon. Obes Surg. 2004 Aug;14(7):991-8. doi: 10.1381/0960892041719671.
PubMed 15329191Alfalah H, Philippe B, Ghazal F, Jany T, Arnalsteen L, Romon M, Pattou F. Intragastric balloon for preoperative weight reduction in candidates for laparoscopic gastric bypass with massive obesity. Obes Surg. 2006 Feb;16(2):147-50. doi: 10.1381/096089206775565104.
PubMed 16469215Vicente Martin C, Rabago Torre LR, Castillo Herrera LA, Arias Rivero M, Perez Ferrer M, Collado Pacheco D, Martin Rios MD, Barba Martin R, Ramiro Martin J, Vazquez-Echarri J, Herrera Merino N. Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay. Surg Endosc. 2020 Jun;34(6):2519-2531. doi: 10.1007/s00464-019-07061-w. Epub 2019 Aug 9.
PubMed 31399943
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity
- ClinicalTrials.gov ID
- NCT01998243
- Acronym / sponsor ID
- fis PI070682
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, bioenterics intragastric balloon, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hospital Severo OchoaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2009
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: bariatric surgery shows an important morbidity and there are some reports that have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity.
Patients Methods: Since 2009 we are performing a randomized and prospective study to assess the usefulness of (IGB-BIB®) before bariatric surgery [sleeve resection (SR) or gastric bypass (GB)] "group A". The intervention in this group was was to place an intragastric Balloon for 6 months vs a control group "B" with the same type of surgical procedures but without preoperative IGB-BIB.The intervention on this group was only to treat the obesity only with diet for 6 months . All patients coming for both groups were followed at 4-week intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least 30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery was associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB failure.Intragastric balloon failure was considered when the weight loss is less than 10% from the initial weight. We defined severe complication whenever the patient had to be admitted in the hospital after discharge, new surgeries or transfusions were required or the hospital stay was longer than 7-10 days.
Detailed description
Treatment with an intragastric balloon (IGB) for morbid obesity is a temporary treatment reached as a second step, when the initial nutritional multidisciplinary approach has failed; however, its value is not clear compared with other conventional medical treatments ], though some authors have stated that IGB achieves higher weight loss than conventional diet treatments (12.2% of the initial weight) ]; and others have positioned IGB as the first valid step in order to achieve weight loss in patients who are adequate for a future gastric bypass surgery. Genco et al (2009) have compared the treatment with IGB only vs. laparoscopic sleeve gastrectomy (LSG), and have found no differences in the amount of weight loss at 6 months, but a reduction in adverse events caused by IGB treatment.
One of the potential future indications for the intragastric balloon could be its use as a bridge-treatment until bariatric surgery, not only in order to achieve weight loss before surgery, but also to select the group of patients who might benefit more from derivative surgery, as suggested by some authors or its use in special populations such as super-obese patients . The objective would be to reduce weight before the surgical procedure, in order to improve comorbidities, facilitate the surgical technique, and potentially reduce any surgical complications.
It is increasingly frequent in many surgical units to try and achieve weigh loss before bariatric surgery, using intragastric balloons (IGB). However, this therapeutic approach currently presents dubious utility. Our study intends to contribute with our experience in the evaluation of IGB before surgery for achieving weight loss, and its impact on post-surgical morbidity.
Bariatric surgery shows an important morbidity and there are not to many randomized prospective studies using intragastric- balloons (IGB-BIB®) to evaluate if getting weight lost really matter on decreasing surgical complications before Bariatric surgery OBJECTIVE: To study the usefulness of preoperative IGB-BIB® "grA" [sleeve resection (SR) or gastric bypass (GB)] to help decrease postsurgical complications. Secondly we try to check the rate of IGB-BIB® failures (a total weight loss less than 10% of the initial weight), and the impact on decreasing hospital stay and rate of surgical reoperations. METHODS: The study was a clinical prospective and randomized essay coming from 2009. Cases (grA) had an IGB during 6 months before surgery vs Controls (grB)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGB group A | Experimental | Device: Intragastric Balloon (IGB), group A, Other: diet, control group Bthe intervention in the group A : was to place a preoperative intragastric balloon (IGB-BIB®) in the stomach for 6 months before surgery plus an hypocaloric diet 1200 Kilocalories (Kcal) |
| control group B | Placebo comparator | Other: diet, control group Bthe intervention in this control group B was the specified diet (a hypocaloric diet of 1200 Kilocalories (Kcal) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Morbid obesity (BMI ≥ 40 kg/m2 ) with a failed Conventional Medical treatment
- - Morbid obesity (BMI ≥ 35 kg/m2) with important comorbidity with a failed Conventional Medical treatment
- - they should be operated by a laparoscopic gastric sleeve or by laparoscopic gastric by-pass
Key exclusion criteria (14 listed)
- - Slight adherence to previous medical treatments .
- - Hiatal hernia more than 3 cms
- - Patients with active gastric or duodenal ulcer disease
- - Severe esophagitis
- - Psychiatric diseases (depression, bulimia etc)
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 |
|---|---|---|
| Intragastric Balloon (IGB), group AAlso: BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEMthe intervention was to place An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM) endoscopically under conscious sedation and was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors (PPI), and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems | Device | IGB group A |
| diet, control group BAlso: 1200 Kilocalories (Kcal) dietthe intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet | Other | IGB group A, control group B |
Primary outcome
Postsurgical Morbidity on Both Arms of the Study
Time frame: within the 90 days after surgery
postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
Total Postsurgical Morbidity
Time frame: during the 6 months having the intragastric balloon and 90 days after surgery
total postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of "The accordion severity grading system ".
3 secondary outcomes
Hospital Stay,
Time frame: the period of the study started when patients were randomizated and finished 90 days after surgery
Rate of Surgical Conversion to Open Surgery
Time frame: during the initial laparoscopic surgery
Percentage of Re-operations
Time frame: during all the period of the study ending within 90 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11433910Hodson RM, Zacharoulis D, Goutzamani E, Slee P, Wood S, Wedgwood KR. Management of obesity with the new intragastric balloon. Obes Surg. 2001 Jun;11(3):327-9. doi: 10.1381/096089201321336692.
- Background: PubMed 11433911Loffredo A, Cappuccio M, De Luca M, de Werra C, Galloro G, Naddeo M, Forestieri P. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001 Jun;11(3):330-3. doi: 10.1381/096089201321336700.
- Background: PubMed 12194556Doldi SB, Micheletto G, Perrini MN, Librenti MC, Rella S. Treatment of morbid obesity with intragastric balloon in association with diet. Obes Surg. 2002 Aug;12(4):583-7. doi: 10.1381/096089202762252398.
- Background: PubMed 15186637Busetto L, Segato G, De Luca M, Bortolozzi E, MacCari T, Magon A, Inelmen EM, Favretti F, Enzi G. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg. 2004 May;14(5):671-6. doi: 10.1381/096089204323093471.
- Background: PubMed 15329191Sallet JA, Marchesini JB, Paiva DS, Komoto K, Pizani CE, Ribeiro ML, Miguel P, Ferraz AM, Sallet PC. Brazilian multicenter study of the intragastric balloon. Obes Surg. 2004 Aug;14(7):991-8. doi: 10.1381/0960892041719671.
- Background: PubMed 16469215Alfalah H, Philippe B, Ghazal F, Jany T, Arnalsteen L, Romon M, Pattou F. Intragastric balloon for preoperative weight reduction in candidates for laparoscopic gastric bypass with massive obesity. Obes Surg. 2006 Feb;16(2):147-50. doi: 10.1381/096089206775565104.
- Derived from this study: PubMed 31399943Vicente Martin C, Rabago Torre LR, Castillo Herrera LA, Arias Rivero M, Perez Ferrer M, Collado Pacheco D, Martin Rios MD, Barba Martin R, Ramiro Martin J, Vazquez-Echarri J, Herrera Merino N. Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay. Surg Endosc. 2020 Jun;34(6):2519-2531. doi: 10.1007/s00464-019-07061-w. Epub 2019 Aug 9.
- 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.
Luis R Rábago, MD,PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intragastric Balloon (IGB), group A in people with Morbid Obesity, run by Hospital Severo Ochoa at 1 site in Spain.
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 14 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 10 Jun 2019. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postsurgical Morbidity on Both Arms of the Study (time frame: within the 90 days after surgery). The study lists 2 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 NCT01998243, 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 10 Jun 2019.