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A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects (ReShapePAS)

28. marts 2019 opdateret af: ReShape Lifesciences
The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The ReShape Post Approval Study is a post-approval, multicenter, single arm, open label clinical study intended to collect valid scientific evidence regarding the safety and efficacy of the ReShape Dual Balloon as an adjunct to diet and exercise in the treatment of BMI 30-40 subjects with one or more obesity-related comorbid conditions in a commercial clinical setting.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

186

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Dothan, Alabama, Forenede Stater, 36305
        • Digestive Health Specialists Of The Southeast
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Christiana Institute of Advanced Surgery
    • Illinois
      • Barrington, Illinois, Forenede Stater, 60010
        • Barrington Surgeons
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • The Gastro Clinic
      • Metairie, Louisiana, Forenede Stater, 70001
        • Surgical Specialist of Louisiana
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University
    • New Jersey
      • Teaneck, New Jersey, Forenede Stater, 07666
        • North Jersey Laparoscopic Associates
    • New York
      • Roslyn Heights, New York, Forenede Stater, 11577
        • New York Bariatric Group
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45241
        • JourneyLite Physicians
      • Salem, Ohio, Forenede Stater, 44460
        • Salem General Surgery
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Gastrointestinal Associates, P.C.
      • Memphis, Tennessee, Forenede Stater, 38120
        • MidSouth Bariatrics
    • Texas
      • San Antonio, Texas, Forenede Stater, 78240
        • Sage Bariatric Institute
    • Washington
      • Shoreline, Washington, Forenede Stater, 98155
        • Eviva

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

22 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Obese patients with a body mass index (BMI) of 30-40 and one or more obesity-related comorbid conditions, who have failed weight reduction with diet and exercise alone

Beskrivelse

Inclusion Criteria:

  1. Ages 22 and older
  2. Baseline BMI 30 - 40
  3. Failed weight reduction with diet and exercise alone
  4. One or more obesity-related comorbid conditions
  5. If female of child bearing potential, willing to avoid pregnancy during course of treatment

Exclusion Criteria:

  1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
  2. Prior open or laparoscopic bariatric surgery.
  3. Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
  4. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
  5. A gastric mass.
  6. A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
  7. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
  8. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
  9. Severe coagulopathy
  10. Hepatic insufficiency or cirrhosis
  11. Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
  12. Alcoholism or drug addiction.
  13. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  14. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
  15. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
  16. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
  17. Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device.
  18. Patients who are pregnant or breast-feeding.
  19. Significant endoscopic abnormalities immediately prior to device insertion.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Study Subjects
Eligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting
Enhed: Reshape Integrated Dual Balloon
Andre navne:
  • Reshape Integrated Dual Balloon System

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety of ReShape Dual Balloon Treatment
Tidsramme: 24 weeks
Safety of ReShape Dual Balloon Treatment using a composite endpoint consisting of all device- and/or procedure-related SAEs
24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ReShape Lifesciences

Efterforskere

  • Studieleder: Scott Shikora, ReShape Lifesciences

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. september 2016

Primær færdiggørelse (Forventet)

1. november 2019

Studieafslutning (Forventet)

1. december 2019

Datoer for studieregistrering

Først indsendt

5. oktober 2016

Først indsendt, der opfyldte QC-kriterier

6. oktober 2016

Først opslået (Skøn)

7. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • ReShape Post Approval Study

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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