- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02443753
EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
Přehled studie
Detailní popis
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
This study will be conducted at a single clinical site in Malaysia. Approximately 16 subjects will be enrolled in two cohorts of 8 subjects. The two cohorts will be implanted one week apart with the implantation of the second cohort triggered by the absence of major technical or clinical issues (i.e. safety, tolerability) observed in the first cohort in the first seven days.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Kuala Lumpur, Malajsie, 50603
- Universiti Malaya Medical Centre, Jalan universiti
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age > 21 years and < 65 years - male or female
- Overweight or obese individuals (BMI ≥ 27 kg/m2 and ≤ 40 kg/m2)
- Diagnosed with Type 2 diabetes and being treated by diet or oral agents (metformin, SU, DPP-4i, or TZD)
- Glycemic state: HbA1c at screening 7.0-10.0%.
- History of failure with non-surgical weight loss methods
- Subjects willing to comply with study requirements
- Subjects who have signed an informed consent form
Exclusion Criteria:
Diabetic subjects requiring injectable treatments (insulin, GLP-1R agonists)
- Subjects requiring anticoagulation therapy
- Subjects with iron deficiency and iron deficiency anemia
- Condition of the gastrointestinal tract, such as ulcers or inflammatory bowel disease
- Treatment represents an unreasonable risk to the subject
- Known history of acute or chronic pancreatitis
- Known history of organ failure (i.e. renal insufficiency, heart failure, fibrotic / cirrhotic liver disease, or pulmonary disease)
- Symptomatic coronary artery disease or pulmonary dysfunction
- Subjects with known symptomatic biliary disease
- Known infection at the time of implant
- Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses
- Pregnant or has the intention of becoming pregnant in the next 6 months
- Unresolved alcohol or drug addiction
- HIV positive subjects
- Subjects with hepatitis B or C
- Currently taking the following medications within 30 days of implant:
systemic corticosteroids, drugs known to affect GI motility, prescription or over the counter weight loss medications such as Sibutramine hydrochloride monohydrate and Orlistat
- Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
- Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement in this clinical trial
- Previous GI surgery that could affect the ability to place the liner or the function of the implant.
- Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- H. pylori positive subjects (Note: patients may be enrolled if they had a prior history and were successfully treated).
- Family or subject history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Unable to tolerate proton pump inhibitors
- Participating in another ongoing investigational clinical trial that is ongoing or within 3 months of the implant date
- Positive stool guaiac at time of screening
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Device
Subjects who receive the device
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Eligible subjects will be implanted with the EndoBarrier® SANS™ Device for a period of 3 months.
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis.
The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.
Časové okno: 3 months
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Safety will be evaluated as the incidence of AEs and SAEs/UADEs.
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3 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Efficacy as measured by Change in Body weight
Časové okno: 3 months
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Change in Body weight
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3 months
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Efficacy as measured by Percent excess weight loss
Časové okno: 3 months
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Percent excess weight loss
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3 months
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Efficacy as measured by Change in HbA1c (%)
Časové okno: 3 months
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Change in HbA1c (%)
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3 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Eng Hong Pok, MD, University of Malaya
- Vrchní vyšetřovatel: Wah Kheong Chan, MD, University of Malaya
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 15-1
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