ObesityMILEPOSTNCT01843231
Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone
A study testing g-CathTM EZ Suture Anchor Delivery Catheter in people with Obesity, run by USGI Medical at 3 sites in 3 countries.
Trial summary
This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- g-CathTM EZ Suture Anchor Delivery Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2013to 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-60 years
- Body Mass Index [BMI] of >30 and <40 with or without a co-morbid condition
- Subject 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-Physical Status score ≤ 2 (Appendix III),
- Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
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- Has not taken any prescription or over the counter weight loss medications for at least 6 months,
- Signed informed consent.
- Subject is willing to cooperate with post-operative dietary recommendations and assessment tests,
Who cannot join
- History of (or intraoperative evidence of) bariatric, gastric or esophageal surgery
- Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
- Severe gastroesophageal 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 >3 centimeters by history or as determined by Upper Gastrointestinal exam or endoscopy
- Pancreatic insufficiency/disease
- Active peptic ulcer
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- Pregnancy or plans of pregnancy in the next 12 months
- Present Corticosteroid Use
- History of inflammatory disease of Gastrointestinal [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 [DM] (as defined by Glycosylated Hemoglobin [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 [drug use] questionnaires or positive Urinalysis [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 [Beck Depression Inventory [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
- Subject is not able to provide written informed consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss [TBWL] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.
Read the detailed description
This study will evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. The weight loss outcomes will be used to assess treatment effect. This study is a multi-center, open/unblinded, prospective randomized feasibility study (3:1Treatment: Control) study. Patients in the control group will be offered the opportunity to crossover to the treatment group at 12 months.
- Conditions
- Obesity
- Being tested
- g-CathTM EZ Suture Anchor Delivery Catheter, Diet and Exercise Control Group
- Keywords
- g-Cath EZ Suture Anchor Delivery Catheter, Weight Loss Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
g-CathTM EZ Suture Anchor Delivery CatheterDevice
Use of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group
Diet and Exercise Control GroupOther
Patients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group
| Study group | Role | What they receive |
|---|---|---|
| g-Cath EZ Treatment Group | Experimental | Evaluate the safety and effectiveness of the g-CathTM EZ Suture Anchor Delivery Catheter as an early weight loss intervention Receives: Device: g-CathTM EZ Suture Anchor Delivery Catheter |
| Diet and exercise Control Group | Active comparator | Diet and Exercise only control group Receives: Other: Diet and Exercise Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Incidence and severity of Adverse Events [AE] over 12 Months
Measured: 12 months
Primary Efficacy Endpoint
Mean % TBWL at 12 months for Treatment subjects compared to Control subjects
Measured: 12 months
Co-Primary Efficacy Endpoint
The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months
Measured: 12 months
Secondary outcomes (4)
First Secondary Efficacy Endpoint
Mean % TBWL at 24 months.
Measured: 24 months
Second Secondary Efficacy endpoint
Proportion of subjects achieving ≥ 5% TBWL at 24 months
Measured: 24 months
Third Secondary Efficacy endpoint
Satiety changes (volume and time to satiety at 2, 6, 12 months post-procedure)
Measured: 2, 6, 12 months
Fourth Secondary Efficacy endpoint
% Estimated Weight Loss [EWL] at 12 months and 18 months [% EWL will be calculated using BMI-25 criteria]
Measured: 12 & 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015 (estimated)
- Study completionAug 2016 (estimated)
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge C. Espinos, Dr., Principal investigator, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843231
- Sponsor's protocol ID
- 41936
- Acronym
- MILEPOST
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller K, Turro R, Greve JW, Bakker CM, Buchwald JN, Espinos JC. MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy. Obes Surg. 2017 Feb;27(2):310-322. doi: 10.1007/s11695-016-2295-9.
PubMed 27468907
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
- A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
- ClinicalTrials.gov ID
- NCT01843231
- Acronym / sponsor ID
- MILEPOST / 41936
- Conditions
- Obesity
- Keywords
- g-Cath EZ Suture Anchor Delivery Catheter, Weight Loss Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 30 Apr 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 study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss [TBWL] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.
Detailed description
This study will evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. The weight loss outcomes will be used to assess treatment effect. This study is a multi-center, open/unblinded, prospective randomized feasibility study (3:1Treatment: Control) study. Patients in the control group will be offered the opportunity to crossover to the treatment group at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| g-Cath EZ Treatment Group | Experimental | Device: g-CathTM EZ Suture Anchor Delivery CatheterEvaluate the safety and effectiveness of the g-CathTM EZ Suture Anchor Delivery Catheter as an early weight loss intervention |
| Diet and exercise Control Group | Active comparator | Other: Diet and Exercise Control GroupDiet and Exercise only control group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 20-60 years
- Body Mass Index [BMI] of >30 and <40 with or without a co-morbid condition
- Subject 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-Physical Status score ≤ 2 (Appendix III),
Key exclusion criteria (29 listed)
- History of (or intraoperative evidence of) bariatric, gastric or esophageal surgery
- Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
- Severe gastroesophageal 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 >3 centimeters by history or as determined by Upper Gastrointestinal exam or 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-CathTM EZ Suture Anchor Delivery CatheterUse of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group | Device | g-Cath EZ Treatment Group |
| Diet and Exercise Control GroupPatients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group | Other | Diet and exercise Control Group |
Primary outcome
Primary Safety Endpoint
Time frame: 12 months
Incidence and severity of Adverse Events [AE] over 12 Months
Primary Efficacy Endpoint
Time frame: 12 months
Mean % TBWL at 12 months for Treatment subjects compared to Control subjects
Co-Primary Efficacy Endpoint
Time frame: 12 months
The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months
4 secondary outcomes
First Secondary Efficacy Endpoint
Time frame: 24 months
Second Secondary Efficacy endpoint
Time frame: 24 months
Third Secondary Efficacy endpoint
Time frame: 2, 6, 12 months
Fourth Secondary Efficacy endpoint
Time frame: 12 & 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 27468907Miller K, Turro R, Greve JW, Bakker CM, Buchwald JN, Espinos JC. MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy. Obes Surg. 2017 Feb;27(2):310-322. doi: 10.1007/s11695-016-2295-9.
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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, Dr. principal investigator
Centro Medico Teknon
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing g-CathTM EZ Suture Anchor Delivery Catheter in people with Obesity, run by USGI Medical at 3 sites in 3 countries.
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 9 inclusion and 29 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: status not confirmed, 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 3 sites in Austria, Netherlands, 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?
Results are not available in the source record.
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?
Primary Safety Endpoint (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT01843231, 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 3 Apr 2015.