- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02283632
A Trial of the Jejunal Diversion Procedure
28. juni 2016 opdateret af: Ethicon Endo-Surgery
A Trial of the Jejunal Diversion Procedure (Side-to-side Jejuno-jejunostomy) (Europe)
This is a single site trial to assess metabolic effects in subjects after a Jejunal Diversion procedure was performed.
Studieoversigt
Detaljeret beskrivelse
The Jejunal Diversion procedure is an adaptation of a jejuno-jejunostomy, which is a surgical procedure often used to address a mix of pathological conditions.
The safety of the Jejunal Diversion procedure is not in question, but rather understanding the gastrointestinal signalling effects.
Up to 25 eligible subjects will be enrolled into the trial.
Enrollment will stop once 15 subjects have undergone the Jejunal Diversion procedure
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Prague, Tjekkiet
- OB Klinika
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 20 to 60 years of age (inclusive) on the date the ICD is signed
- A BMI ≥ 27 kg/m2 and < 40 kg/m2
- HbA1c ≥ 8% (63.9 mmol/mol) and ≤ 11% (96.7 mmol/mol)
- C-peptide ≥ 3 ng/mL (0.999 nmol/L)
At least one of the following:
- Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, or on anti-hypertensive medication
- HDL < 40 mg/dL (1.0344 mmol/L) (men) or < 50 mg/dL (1.293 mmol/L) (women), or on medication for low HDL
- LDL > 100 mg/dL (2.586 mmol/L), or on medication for high LDL
- TG ≥ 150 mg/dL (1.694 mmol/L) or on TG lowering medication treatment
- FPG ≥ 100 mg/dL (5.556 mmol/L) or on medication for hyperglycemia or anti-T2DM
- Able to comprehend and sign the EC-approved trial ICD
Exclusion Criteria:
- Unable or unwilling to attend follow-up visits and examinations
- History of drug and/or alcohol abuse within 2 years of Screening Visit
- Any previous major GI surgery (e.g., any GI surgery with a resection, etc.) Examples of previous GI surgery allowed include: appendectomy, gall bladder surgery, liver biopsies, endoscopic procedures, etc.
- Scheduled concurrent surgical procedure
- Women of childbearing potential who are pregnant or lactating at the time of screening, at the time of surgery, or planning to become pregnant during the follow-up period
- Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression, or history of suicide attempts
Any condition which precludes compliance with the trial, including:
- Inflammatory diseases of the GI tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years
- History of Hepatitis B or C
- T1DM
- LADA (confirmed by positive GAD autoantibodies, IAA, and ICA)
- Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders
Screening laboratory tests with any of the following:
- ALT and/or AST levels ≥ 4 times ULN according to laboratory normal ranges
- Blood creatinine level ≥ 1.5 times ULN according to laboratory normal ranges
- BUN level ≥ 1.5 times ULN according to laboratory normal ranges
Use of any of the following medications in the past 120 days:
- Chronic steroid use
- Prescription or over-the-counter medications or supplements with a primary indication known to cause or assist in weight reduction
Use of any of the following medications in the past 60 days:
a. Promotility agents
- Any other medical condition or finding for which, at the discretion of the PI, the subject should be excluded
- Participation in any other clinical trial (not to include registries or survey-only studies) within 30 days or 5 half lives of an investigational drug (which ever is longer), of Visit 1 (Screening Visit) and for the duration of the trial
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Jejunal Diversion
all subjects who receive jejunal diversion surgery
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The jejuno-jejunostomy surgical procedure is a well-known general surgical operation performed for multiple acute and chronic conditions including Crohn's disease, ovarian cancer, and small bowel obstruction.
The jejunal diversion procedure is an adaptation of a jejuno-jejunostomy.
The proximal end of the anastomosis is approximately 100 cm distal from the ligament of Treitz.
The distal end of the anastomosis is approximately 250 cm proximal from the ileocecal junction.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Assess change in glycosylated hemoglobin A1c
Tidsramme: 12 months
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Robin Scamuffa, Ethicon, Inc.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2014
Primær færdiggørelse (Faktiske)
1. maj 2016
Studieafslutning (Faktiske)
1. maj 2016
Datoer for studieregistrering
Først indsendt
31. oktober 2014
Først indsendt, der opfyldte QC-kriterier
3. november 2014
Først opslået (Skøn)
5. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ESC-14-001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Jejunal Diversion
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Meshalkin Research Institute of Pathology of CirculationUkendtIntrakraniel aneurismeDen Russiske Føderation
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Massachusetts General HospitalMassachusetts Department of HealthTilmelding efter invitationStofbrug | Sundhedsrisikoadfærd | Teenagers adfærd | UngdomForenede Stater
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Magnolia Medical Technologies, Inc.AfsluttetSeptikæmiForenede Stater
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University Hospital Plymouth NHS TrustAfsluttetKirurgisk resektion af en øvre gastrointestinal malignitet | Kosttilskud via en jejunostomi efter udskrivelse fra hospitalDet Forenede Kongerige
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Boston Scientific CorporationAfsluttet
-
Sound Shore Medical Center of WestchesterMaffucci L, Rangraj MAfsluttetType 2 diabetes mellitusForenede Stater
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Ferzli, George S., M.D. F.A.C.S.Ukendt
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University of Campinas, BrazilEthicon Endo-SurgeryAfsluttetDiabetes mellitus, type 2Brasilien
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Sun Yat-sen UniversityUkendtErnæringsforstyrrelser | MavekræftKina
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University Hospital of North NorwayAfsluttet