The primary objective of this study is:* To evaluate the safety and effectiveness of the g-Cath* EZ Delivery Catheter with Snowshoe Suture Anchors* gastric procedure as an weight loss intervention compared to diet and exercise only.A key secondary…
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Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy hypotheses:
* Mean %TBWL in the Treatment group will be * 5 % higher than the Control group
at 12 months
* The proportion of subjects achieving * 5% total body weight loss at 12 months
will be >50% in Treatment group
Secondary outcome
Secondary efficacy hypotheses:
* The proportion of patients achieving improvement of quality of life at 12
months will be larger in the Treatment group than in the Control group
* There will be significant differences in both time to satiety and caloric
capacity in the Treatment group as compared to the Control group at all
time-points following the intervention
Background summary
Rationale for Study
Even with the current bariatric treatment options available today, it is clear
that there is still a need for minimally invasive procedures that provide safe
and effective long-term weight loss results without the risks of surgery and
without the limitations of temporary implants. USGI Medical, in collaboration
with experts in the field, has developed a new endoscopic procedure to provide
a safe and effective treatment option for patients with Class I or II Obesity.
The procedure involves the creation of pleats in the fundus and distal body of
the stomach with the intent to reduce stomach capacity and produce early
satiety. Patients have reported less hunger and cravings after the procedure
along with less food capacity. Like all other bariatric interventions, however,
it is expected practice that a strict diet regimen be prescribed for all
patients after the procedure. A tailored after care programme, with a
prescribed diet, are standard practice for all weight loss interventions,
including all standard bariatric procedures.
Weight loss results have been very promising and procedure complications have
been less than 1.5% to date.The POSE* procedure is not a temporary intervention
such as a balloon or intestinal barrier. It does not require revisions or
removal and it does not limit follow-on procedures in the event that obesity
progresses and surgery is required in later years. The procedure may provide
additional benefits over diet and exercise alone with the intent of
establishing long-term weight loss and resultant improvement in patient
co-morbidities.
Therefore, we are conducting a RCT to compare the long-term weight loss results
of patients undergoing the POSE procedure plus diet and exercise with those
following a diet and exercise regime only. The patients and the aftercare
requirements will be identical in both groups, thereby permitting fair and
accurate isolation of the treatment effect. This places the proposed
feasibility study in-line with the latest thinking on the subject and provides
the investigators an opportunity to make a meaningful contribution to the
science of this area.
Study objective
The primary objective of this study is:
* To evaluate the safety and effectiveness of the g-Cath* EZ Delivery Catheter
with Snowshoe Suture Anchors* gastric procedure as an weight loss intervention
compared to diet and exercise only.
A key secondary objective of this study is:
* To pool the weight loss data from this study with outcome data from previous
studies to assess an overall treatment effect.
Study design
This RCT is using a multicenter, randomized, open-label, parallel-group,
controlled study design intended to evaluate the safety and effectiveness of
treating patients with primary obesity using the g-Cath* EZ Delivery Catheter
with Snowshoe Suture Anchors* gastric procedure plus diet and exercise compared
to diet and exercise alone.
Subjects will be randomly assigned in a 3:1 ratio to the Treatment and Control
groups. Block randomizations with a block size of 4 (3 Treatment and 1
Control), will be carried out separately at each site. Randomization
assignments will be generated by an independent statistician and assigned to
each consecutive subject through an electronic data capture system.
Intervention
Gastric plication
Diet and excercise
Study burden and risks
Similar to regular bariatric surgery, with the exception of the surgical risks
that are less because of the less invasive nature of this procedure.
Calle Cordillera 1140
San Clemente, California 92673
US
Calle Cordillera 1140
San Clemente, California 92673
US
Listed location countries
Age
Inclusion criteria
* Age 20-60 years
* BMI of >30 and <40 with or without a co-morbid condition
* Patient has failed more conservative weight reduction alternatives such as supervised diet, exercise or behavior modification programs in the last year
* No significant weight change (+/- 5% of total body weight) in last 6 months
* American Society Anesthesiologists-PS score * 2 (Appendix III)
* Has not taken any prescription or over the counter weight loss medications for at least 6 months
* Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
* Subject is willing to cooperate with post-operative dietary recommendations and assessment tests
* Signed informed consent
Exclusion criteria
* History of (or intra-operative evidence of) 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
* Known hiatal hernia >3cm by history or as determined by UGI exam or endoscopy
* Pancreatic insufficiency/disease
* Active peptic ulcer
* Pregnancy or plans of pregnancy in the next 12 months
* Present Corticosteroid Use
* History of inflammatory disease of 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 2 years at the time of enrollment
* Uncontrolled Type II DM (HgbA1c >7.0 at screening)
* Quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
* Immunosuppression
* Portal hypertension and/or varices
* Active gastric ulcer disease
* Gastric outlet obstruction or stenosis
* Beck Depression Inventory (Short) Score *12 (see Appendix IV)
* Subject has a history of drug or alcohol abuse or actively abusing either as defined by Cage and DAST questionnaires or positive UA drug screen
* Severe disturbances in eating behavior (i.e. binge eating)
* Known presence of a significant depression, psychosis, or other mood or eating disorder
* Actively treated depression (except for stable treated depression for >1year and normal BDI and psych exam)
* Present or past history of psychosis or other mood or eating disorder
* 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 first degree relative of investigator, or support staff involved in the study
* Employed by investigator or institution involved in the study or relative of same
* Subject is not able to provide written informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01843231 |
| CCMO | NL46567.096.13 |