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ESSENTIAL Trial™ Sham Cross-over

31 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

73

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 23 anni a 61 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Percent Total Body Weight Loss
Lasso di tempo: 1 Year
Percent total body weight loss calculated through 12 months post procedure
1 Year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

USGI Medical

Investigatori

  • Investigatore principale: Tom Lavin, MD, Crescent City Surgical Centre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 gennaio 2015

Completamento primario (Effettivo)

31 agosto 2016

Completamento dello studio (Effettivo)

30 settembre 2016

Date di iscrizione allo studio

Primo inviato

23 ottobre 2014

Primo inviato che soddisfa i criteri di controllo qualità

27 ottobre 2014

Primo Inserito (Stima)

31 ottobre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • TPR 50402

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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