ObesityNCT02279420
ESSENTIAL Trial™ Sham Cross-over
A study testing g-Cath EZ™ Suture Anchor Delivery Catheter in people with Obesity, run by USGI Medical at 11 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 23 to 61 years
- Conditions the study is for
- Obesity
- What is being tested?
- g-Cath EZ™ Suture Anchor Delivery Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 11 sitesUnited States
- Study dates
- 5 Jan 2015to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide written informed consent.
- Potential subject was sham participant in the Essential pivotal trial
- Potential subject agrees to be compliant with study and has a documented history of compliance in pivotal study.
- Subjects between the ages of 23-61 years.
- 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.
- 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)
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- 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)
- Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
- 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).
- Be willing to cooperate with post-operative dietary recommendations and assessment tests.
- 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.
Who cannot join
- History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
- Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments or procedure execution.
- 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.
- Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
- Pancreatic insufficiency/disease.
- History of gastroparesis or symptoms that would be suggestive of gastroparesis.
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- Pregnancy or plans of pregnancy in the next 12 months.
- Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
- History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
- History or present use of insulin or insulin derivatives for treatment of diabetes
- Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment
- If smoker, plans to quit smoking in the year after enrollment
- Portal hypertension and/or varices.
- 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.
- Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
- Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment
- Non-ambulatory or has significant impairment of mobility.
- Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
- Participating in another clinical study except for Essential Study.
- Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Hamilton Medical Center
Dalton, Georgia, 30720
Northshore/Evanston Hospital
Evanston, Illinois, 60201
Saint Luke's Hospital
Kansas City, Missouri, 64111
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Crescent City Surgical
Metairie, Louisiana, 70001
University of Miami Hospital
Miami, Florida, 33166
Fairview UMMC-University
Minneapolis, Minnesota, 55455
Shea Campus -Scottsdale Healthcare
Scottsdale, Arizona, 85258
WA University School of Medicine
St Louis, Missouri, 63110
Lexington Medical Center
West Columbia, South Carolina, 29169
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- g-Cath EZ™ Suture Anchor Delivery Catheter
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
g-Cath EZ™ Suture Anchor Delivery CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Essential Study Sham Cross-over | Other | 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. Receives: Device: g-Cath EZ™ Suture Anchor Delivery Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Total Body Weight Loss
Percent total body weight loss calculated through 12 months post procedure
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start5 Jan 2015
- Primary completion31 Aug 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Lavin, MD, Principal investigator, Crescent City Surgical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279420
- Sponsor's protocol ID
- TPR 50402
- Status last verified
- Mar 2017
- First submitted
- 23 Oct 2014
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02279420
- Acronym / sponsor ID
- TPR 50402
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essential Study Sham Cross-over | Other | Device: g-Cath EZ™ Suture Anchor Delivery CatheterDevice: 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. |
Who may qualify
- Ages
- 23 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provide written informed consent.
- Potential subject was sham participant in the Essential pivotal trial
- Potential subject agrees to be compliant with study and has a documented history of compliance in pivotal study.
- Subjects between the ages of 23-61 years.
- 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.
Key exclusion criteria (20 listed)
- History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
- Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments or procedure execution.
- 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.
- Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
- Pancreatic insufficiency/disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| g-Cath EZ™ Suture Anchor Delivery CatheterThis 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. | Device | Essential Study Sham Cross-over |
Primary outcome
Mean Percent Total Body Weight Loss
Time frame: 1 Year
Percent total body weight loss calculated through 12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Lavin, MD principal investigator
Crescent City Surgical Centre
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing g-Cath EZ™ Suture Anchor Delivery Catheter in people with Obesity, run by USGI Medical at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Total Body Weight Loss (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.