- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01753609
Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
17. december 2012 opdateret af: Tulip Medical Ltd.
Safety and Performance Evaluation of TrimWeight Device - an Intragastric Auto-inflating & Degradable Balloon in a Swallow-able Capsule ("the Device"), for Enhancing Satiety and Satiation in Healthy Over Weight and Obese Volunteers
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
Studieoversigt
Detaljeret beskrivelse
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 < BMI≤ 35.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
8
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sigal Fishman, Dr.
- Telefonnummer: 972-3-6974469
- E-mail: sigalf@tlvmc.gov.il
Undersøgelse Kontakt Backup
- Navn: Tair Lapidot, Dr.
- Telefonnummer: 105 972-72-2505995
- E-mail: tair@tulipmed.com
Studiesteder
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center , Gastroenterology - Institute
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Kontakt:
- Sigal Fishman, Dr.
- Telefonnummer: 972-3-6974469
- E-mail: sigalf@tlvmc.gov.il
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Kontakt:
- Sara Pel
- Telefonnummer: 972-3-6974469
- E-mail: sarap@tlvmc.gov.il
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Underforsker:
- Ron Yishai, Dr
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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
21 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 21 ≤ Age <65 years
- 30 < BMI ≤ 35 kg/m2
- Healthy without any medication;
- No history of weight reduction of more than 5% of total body weight in the past 6 months;
- Normal blood count and chemistry;
- Hemoglobin level over 11;
- At least 3 bowel movements per week;
- Subject declares that he/she is able to go through gastroscopic examination;
- Subject is able and willing to give informed consent and follow protocol procedures.
Exclusion Criteria:
- Any history or evidence of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results;
- History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit);
- History or symptoms of thyroid disease which is not controlled by medication;
- Abnormal gastrointestinal findings: Diaphragmatic hernia > 3 cm; Active peptic ulcer; Erosive gastritis; Gastric outlet obstruction;
- Subject with IBD
- Significant swallowing disorders;
- Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy);
- Malabsorption disorders.
- Is taking medications that reduce gastric acidity
- Currently using pharmaceutical agents or food supplements for weight loss;
- History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
- History of food Allergy;
- Subject with poor venous access;
- Is taking chronic aspirin or other non-steroidal anti-inflammatory agents, or other medications known to be gastric irritants;
- Have any coagulation problem and/or taking any anticoagulant medications;
- Evidence of current malignant disease;
- Have history of any acute disease (viral, bacterial, pain, accident) in the last 6 weeks.
- Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study;
- Inability to give written informed consent;
- History of alcohol or drug abuse within 6 months of screening;
- Mental disorders;
- Currently participating in an ongoing clinical study
- Any reasons making the patient a poor candidate in the opinion of the investigator.
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: Tulip capsule
swallowing Tulip capsule for up to 29 days
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swallowing Tulip capsule for up to 29 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of subjects with device related serious adverse events
Tidsramme: 36 days
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Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference.
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36 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Patient assessment of capsule tolerability
Tidsramme: 36 days
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Comfort and tolerability will be assessed by the patient and will be recorded in a daily diary.
Tolerability evaluation will include: assessment of swallow ability, gastrointestinal comfort, defecation effort, appetite.
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36 days
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Satisfying evacuation of the balloon from the stomach after oral intake
Tidsramme: 36 days
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Number of subjects showing satisfying evacuation of the balloon from the stomach after oral intake by means of a gastroscopic examination
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36 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Sigal Fishman, Dr., Tel Aviv Medical Center
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. januar 2013
Primær færdiggørelse (Forventet)
1. marts 2013
Studieafslutning (Forventet)
1. juli 2013
Datoer for studieregistrering
Først indsendt
17. december 2012
Først indsendt, der opfyldte QC-kriterier
17. december 2012
Først opslået (Skøn)
20. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TULIP-PRT-002-05-B-CTIL
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 .
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