ObesityULTIMATENCT01771276
ULTIMATE Study for Weight Loss
A study testing g-Cath Suture Anchor Delivery Catheter in people with Obesity, run by USGI Medical at 1 site in Spain.
Trial summary
The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- g-Cath Suture Anchor Delivery Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 2013
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has a BMI of >30 and <40
- Male or female ≥21 yrs. of age and < 60 yrs. of age at time of enrollment
- Patient has had no significant weight change (+/- 5% of total body weight) in last 6 months but has been able to lose significant weight in the past with diet and exercise.
- Is a reasonable candidate for general anesthesia
- Agrees not to have any additional weight loss interventional procedures or liposuction for at least 18 months following study enrollment and agrees not to take any prescription or over the counter weight loss medications for at least 1 year.
- Physically and mentally able to comply with the visit schedule, ancillary testing, and behavior modification (diet and exercise) required for the study and agrees to study commitment requirements
- Had successful completion of the pre-screening, nutritional and educational programs and psychological assessment supporting that the subject is an appropriate bariatric surgical candidate
Who cannot join
- 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
- Moderate to severe Gastro-esophageal reflux disease (GERD)
- Known hiatal hernia >3cm by history or as determined by UGI exam or endoscopy
- Known GI motility disorder or pancreatic insufficiency/disease
- Intra-operative Exclusion: Active peptic ulcer or hiatal hernia >3cm
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- Pregnancy.
- Present Corticosteroid Use
- History of inflammatory disease of GI tract
- Severe coagulopathies, hepatic insufficiency or cirrhosis
- History or present use of insulin or insulin derivatives for treatment of diabetes
- Had Type II Diabetes Mellitus (as defined by HgbA1c >6.0) for greater than 2 years at the time of enrollment
- Uncontrolled Type II DM (HgbA1c >7.0 at screening)
- Patient has quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
- Patient has a history of drug or alcohol abuse or actively abusing either
- Patient is presently being treated with medication for depression, psychosis, or other mood or eating disorder
- Non-ambulatory or has significant impairment of mobility
- Works for, or is first degree relative of investigator, study institution, or support staff involved in the study.
- Known hormonal or genetic cause for obesity
- Participating in another clinical study
- Patient is on medications known to impact GI motility or gut hormones that cannot be discontinued prior to nuclear testing
- Have work hours, family obligations or transportation issues that could interfere with patient returning for all scheduled evaluations, tests and nutritional counseling.
- Lives >60 kilometers from investigator site.
- Patient is not able to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Impact of ULTIMATE Number of G-CATH EZ- Suture Anchors Placed Endoscopically on Motility, Metabolism, Satiety, and Weight Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity
The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. In this study, USGI Medical wants to see if stomach emptying and gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared to typical) number of anchors placed.
Read the detailed description
This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the affects of placing more Suture Anchors per patient (as compared to the current practice) in Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors (particularly in the distal body/antrum region) significantly impacts primary weight loss, satiety, and metabolic outcomes.
- Conditions
- Obesity
- Being tested
- g-Cath Suture Anchor Delivery Catheter
- Keywords
- POSE
- 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 Suture Anchor Delivery CatheterDevice
Evaluate changes in emptying, hormones, satiety and weight loss with use of the g-Cath Suture Anchor Delivery Catheter in maximizing g-Cath Suture Anchor placement to as high as 25 anchors.
| Study group | Role | What they receive |
|---|---|---|
| Ultimate Anchor | Experimental | Use of the g-Cath Suture Anchor Delivery Catheter and accessories in placing the ultimate number of anchors for weight loss. Receives: Device: g-Cath Suture Anchor Delivery Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Weight loss will be monitored and recorded on a monthly basis for up to 18 months post POSE with the proportion of subjects achieving ≥25% excess weight loss (EWL) at 12 months (Met Life criteria)being the primary efficacy endpoint
Measured: 18 months
Secondary outcomes (1)
Gastric emptying
This test consists of determining if there is a Clinically significant change in the duration of a radioactive marker (which is non-absorbable, and free of any food components) in a stomach pre and post POSE. In order to carry out this test, a piece of food is marked with a radioactive isotope and, by using an abdominal gamma camera; detections of radioactivity are made in the stomach during the postprandial period.
Measured: Immediately Pre-procedure, & 2 & 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge C Espinos, MD, Principal investigator, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771276
- Sponsor's protocol ID
- TPR602
- Acronym
- ULTIMATE
- Status last verified
- Apr 2015
- First submitted
- 4 Sep 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Impact of ULTIMATE Number of G-CATH EZ- Suture Anchors Placed Endoscopically on Motility, Metabolism, Satiety, and Weight Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity
- ClinicalTrials.gov ID
- NCT01771276
- Acronym / sponsor ID
- ULTIMATE / TPR602
- Conditions
- Obesity
- Keywords
- POSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Jan 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.
The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. In this study, USGI Medical wants to see if stomach emptying and gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared to typical) number of anchors placed.
Detailed description
This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the affects of placing more Suture Anchors per patient (as compared to the current practice) in Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors (particularly in the distal body/antrum region) significantly impacts primary weight loss, satiety, and metabolic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultimate Anchor | Experimental | Device: g-Cath Suture Anchor Delivery CatheterUse of the g-Cath Suture Anchor Delivery Catheter and accessories in placing the ultimate number of anchors for weight loss. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Has a BMI of >30 and <40
- Male or female ≥21 yrs. of age and < 60 yrs. of age at time of enrollment
- Patient has had no significant weight change (+/- 5% of total body weight) in last 6 months but has been able to lose significant weight in the past with diet and exercise.
- Is a reasonable candidate for general anesthesia
- Agrees not to have any additional weight loss interventional procedures or liposuction for at least 18 months following study enrollment and agrees not to take any prescription or over the counter weight loss medications for at least 1 year.
Key exclusion criteria (24 listed)
- 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
- Moderate to severe Gastro-esophageal reflux disease (GERD)
- Known hiatal hernia >3cm by history or as determined by UGI exam or endoscopy
- Known GI motility disorder or 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 Suture Anchor Delivery CatheterEvaluate changes in emptying, hormones, satiety and weight loss with use of the g-Cath Suture Anchor Delivery Catheter in maximizing g-Cath Suture Anchor placement to as high as 25 anchors. | Device | Ultimate Anchor |
Primary outcome
Weight Loss
Time frame: 18 months
Weight loss will be monitored and recorded on a monthly basis for up to 18 months post POSE with the proportion of subjects achieving ≥25% excess weight loss (EWL) at 12 months (Met Life criteria)being the primary efficacy endpoint
1 secondary outcome
Gastric emptying
Time frame: Immediately Pre-procedure, & 2 & 6 months post procedure
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 3 Apr 2015.
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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.
Jorge C Espinos, MD principal investigator
Centro Medico Teknon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing g-Cath Suture Anchor Delivery Catheter in people with Obesity, run by USGI Medical at 1 site in Spain.
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 7 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
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?
Weight Loss (time frame: 18 months). 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 3 Apr 2015.