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ESSENTIAL Trial™ Sham Cross-over

31. března 2017 aktualizováno: USGI Medical

A Supplemental Open Label Multicenter Sham Cross-over Clinical Trial Using an Endoscopic Suturing Device (g-Cath EZ™ Suture Anchor Delivery Catheter) For Primary Weight Loss Essential Study (IDE G130163) Crossover Study

This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.

This supplemental study will consist of up to an 8 week screening period after each subject's unblinding visit, an enrollment (active treatment) day, and a 12-month follow-up period. All sham subjects in the Essential Trial (total quantity of one hundred eleven (111) subjects) are planned for enrollment, but the total quantity of sham subjects provided the active treatment will depend on the number of subjects who are compliant. The active treatment will be provided by the original investigator for that subject at the same investigational center (one of the original 11) used in the Essential trial. Collection of data will be accomplished by utilizing independent nutritionists/clinical research nurses to administer the diet/exercise plan and collect weight loss efficacy assessments. Efficacy assessments will also include changes in select co-morbidities, quality of life assessments, and changes in hunger and satiety, among others. Safety assessments include subject and investigator reported adverse events, physician follow-up assessments, and blood pressure measurements.

Typ studie

Intervenční

Zápis (Aktuální)

73

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Arizona
      • Scottsdale, Arizona, Spojené státy, 85258
        • Shea Campus -Scottsdale Healthcare
    • Florida
      • Miami, Florida, Spojené státy, 33166
        • University of Miami Hospital
    • Georgia
      • Dalton, Georgia, Spojené státy, 30720
        • Hamilton Medical Center
    • Illinois
      • Evanston, Illinois, Spojené státy, 60201
        • Northshore/Evanston Hospital
    • Louisiana
      • Metairie, Louisiana, Spojené státy, 70001
        • Crescent City Surgical
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02115
        • Brigham & Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, Spojené státy, 55455
        • Fairview UMMC-University
    • Missouri
      • Kansas City, Missouri, Spojené státy, 64111
        • Saint Luke's Hospital
      • St. Louis, Missouri, Spojené státy, 63110
        • WA University School of Medicine
    • South Carolina
      • West Columbia, South Carolina, Spojené státy, 29169
        • Lexington Medical Center
    • Tennessee
      • Memphis, Tennessee, Spojené státy, 38120
        • Baptist Memorial Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

23 let až 61 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Provide written informed consent.
  2. Potential subject was sham participant in the Essential pivotal trial
  3. Potential subject agrees to be compliant with study and has a documented history of compliance in pivotal study.
  4. Subjects between the ages of 23-61 years.
  5. If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
  6. Have a Body Mass Index (BMI) of ≥30 and <35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy (See Section 14)
  7. Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease)
  8. Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
  9. Agrees not to utilize any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for 12 months following study enrollment (including all stimulant medication).
  10. Be willing to cooperate with post-operative dietary recommendations and assessment tests.
  11. Residing within a reasonable distance from the Investigator's treating office (~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.

Exclusion Criteria:

  1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
  2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments or procedure execution.
  3. Severe gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
  4. Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
  5. Pancreatic insufficiency/disease.
  6. History of gastroparesis or symptoms that would be suggestive of gastroparesis.
  7. Pregnancy or plans of pregnancy in the next 12 months.
  8. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
  9. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
  10. History or present use of insulin or insulin derivatives for treatment of diabetes
  11. Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment
  12. If smoker, plans to quit smoking in the year after enrollment
  13. Portal hypertension and/or varices.
  14. Significant abnormality identified during Visit 2 (enrollment visit) with endoscopy revealing large hiatal hernia, gastric/duodenal ulcer, gastric erosions, gastric outlet obstruction or stenosis, etc.
  15. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  16. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment
  17. Non-ambulatory or has significant impairment of mobility.
  18. Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
  19. Participating in another clinical study except for Essential Study.
  20. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

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
Jiný: Essential Study Sham Cross-over
Device: g-Cath EZ™ Suture Anchor Delivery Catheter This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
Přístroj: g-Cath EZ™ Suture Anchor Delivery Catheter
This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Percent Total Body Weight Loss
Časové okno: 1 Year
Percent total body weight loss calculated through 12 months post procedure
1 Year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

USGI Medical

Vyšetřovatelé

  • Vrchní vyšetřovatel: Tom Lavin, MD, Crescent City Surgical Centre

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. ledna 2015

Primární dokončení (Aktuální)

31. srpna 2016

Dokončení studie (Aktuální)

30. září 2016

Termíny zápisu do studia

První předloženo

23. října 2014

První předloženo, které splnilo kritéria kontroly kvality

27. října 2014

První zveřejněno (Odhad)

31. října 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. května 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. března 2017

Naposledy ověřeno

1. března 2017

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • TPR 50402

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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