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ESSENTIAL Trial™ Sham Cross-over

31. März 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

73

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

23 Jahre bis 61 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Percent Total Body Weight Loss
Zeitfenster: 1 Year
Percent total body weight loss calculated through 12 months post procedure
1 Year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

USGI Medical

Ermittler

  • Hauptermittler: Tom Lavin, MD, Crescent City Surgical Centre

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Januar 2015

Primärer Abschluss (Tatsächlich)

31. August 2016

Studienabschluss (Tatsächlich)

30. September 2016

Studienanmeldedaten

Zuerst eingereicht

23. Oktober 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Oktober 2014

Zuerst gepostet (Schätzen)

31. Oktober 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Mai 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. März 2017

Zuletzt verifiziert

1. März 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • TPR 50402

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