ObesityNCT01958385
The USGI Medical ESSENTIAL Study for Weight Loss
A study testing placement of g-Cath EZ suture anchors and Diet and Exercise in people with Obesity, run by USGI Medical at 11 sites in United States.
Trial summary
This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same… Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- placement of g-Cath EZ suture anchors and Diet and Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Dec 2013to 1 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide written informed consent.
- Be male or female subjects between the ages of 22-60 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 and 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 and < 40 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.
- Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
- Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
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- Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
- Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.
- Be willing to cooperate with post-operative dietary recommendations and assessment tests.
- Reside 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.
- 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 prescription drug therapy.
- Large hiatal hernia (>3 cm) by history or as determined by pre-randomization endoscopy.
- Pancreatic insufficiency/disease.
- Active gastric erosions or gastric/duodenal ulcer.
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- History of gastroparesis or symptoms that would be suggestive of gastroparesis.
- 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 10 years at the time of enrollment
- Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment
- Portal hypertension and/or varices.
- Gastric outlet obstruction or stenosis.
- Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.
- Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
- Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
- 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 with the exception of treated hypothyroidism.
- Participating in another clinical study.
- Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the 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, 02120
Crescent City Surgical Centre
Covington, Louisiana, 70433
Hamilton Medical Center
Dalton, Georgia, 30722
NorthShore University HealthSystem
Evanston, Illinois, 60201
Saint Luke's Hospital
Kansas City, Missouri, 64111
Baptist Memorial
Memphis, Tennessee, 38120
DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine
Miami, Florida, 33166
University of MN, Fairview Health Services
Minneapolis, Minnesota, 55455
Scottsdale Healthcare
Scottsdale, Arizona, 85258
Washington University School of Medicine
St Louis, Missouri, 63110
Lexington Medical Center
West Columbia, South Carolina, 29169
About this study
Official title: A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS
This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.
- Conditions
- Obesity
- Being tested
- placement of g-Cath EZ suture anchors, Sham procedure, Diet and Exercise
- Keywords
- Total Body Weight Loss
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of g-Cath EZ suture anchorsDevice
Also called g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical)
Sham procedureProcedure or surgery
Diet and ExerciseBehavioural
A structured diet and exercise plan
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise Receives: Device: placement of g-Cath EZ suture anchors; Behavioral: Diet and Exercise |
| Sham Group | Sham comparator | The treatment of obese patients with the sham procedure along with Diet and Exercise Receives: Procedure: Sham procedure; Behavioral: Diet and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Weight Loss
Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.
Measured: Enrollment to 12 months
Secondary outcomes (3)
Quality of Life scores (IWQOL)
Assessment of changes
Measured: enrollment to 12 months
Comorbid status
Assessment of changes from baseline at 12 months in hypertension, diabetes, and hyperlipidemia
Measured: Enrollment to 12 months
Eating Behavior changes
assessment of changes from baseline at 12 months in eating behavior scores (TFEQ) and subjective changes in food capacity, hunger, and satiety in both study groups
Measured: Enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study start1 Dec 2013
- Primary completion1 May 2015
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 377 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 Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958385
- Sponsor's protocol ID
- G130163
- Status last verified
- Mar 2017
- First submitted
- 4 Oct 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sullivan S, Swain JM, Woodman G, Antonetti M, De La Cruz-Munoz N, Jonnalagadda SS, Ujiki M, Ikramuddin S, Ponce J, Ryou M, Reynoso J, Chhabra R, Sorenson GB, Clarkston WK, Edmundowicz SA, Eagon JC, Mullady DK, Leslie D, Lavin TE, Thompson CC. Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial. Obesity (Silver Spring). 2017 Feb;25(2):294-301. doi: 10.1002/oby.21702. Epub 2016 Dec 21.
PubMed 28000425
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS
- ClinicalTrials.gov ID
- NCT01958385
- Acronym / sponsor ID
- G130163
- Conditions
- Obesity
- Keywords
- Total Body Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
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, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: placement of g-Cath EZ suture anchors, Behavioral: Diet and ExerciseThe treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise |
| Sham Group | Sham comparator | Procedure: Sham procedure, Behavioral: Diet and ExerciseThe treatment of obese patients with the sham procedure along with Diet and Exercise |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provide written informed consent.
- Be male or female subjects between the ages of 22-60 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 and 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 and < 40 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.
- Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
Key exclusion criteria (24 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.
- 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 prescription drug therapy.
- Large hiatal hernia (>3 cm) by history or as determined by pre-randomization 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 |
|---|---|---|
| placement of g-Cath EZ suture anchorsAlso: g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical) | Device | Treatment group |
| Sham procedure | Procedure or surgery | Sham Group |
| Diet and ExerciseA structured diet and exercise plan | Behavioural | Sham Group, Treatment group |
Primary outcome
Total Body Weight Loss
Time frame: Enrollment to 12 months
Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.
3 secondary outcomes
Quality of Life scores (IWQOL)
Time frame: enrollment to 12 months
Comorbid status
Time frame: Enrollment to 12 months
Eating Behavior changes
Time frame: Enrollment to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Results publication: PubMed 28000425Sullivan S, Swain JM, Woodman G, Antonetti M, De La Cruz-Munoz N, Jonnalagadda SS, Ujiki M, Ikramuddin S, Ponce J, Ryou M, Reynoso J, Chhabra R, Sorenson GB, Clarkston WK, Edmundowicz SA, Eagon JC, Mullady DK, Leslie D, Lavin TE, Thompson CC. Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial. Obesity (Silver Spring). 2017 Feb;25(2):294-301. doi: 10.1002/oby.21702. Epub 2016 Dec 21.
- Individual participant dataSharing planned: No
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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 Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing placement of g-Cath EZ suture anchors and Diet and Exercise 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 10 inclusion and 24 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 4 Apr 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Body Weight Loss (time frame: Enrollment to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958385, which also lists 1 linked publication.
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 4 Apr 2017.