ObesityPROMISENCT01662024
Endoscopic Suturing for Primary Obesity Treatment
A study testing Endoscopic gastric restrictive procedure in people with Obesity and Body Weight, run by Brigham and Women's Hospital at 4 sites in United States.
Trial summary
Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Body Weight, Overweight
- What is being tested?
- Endoscopic gastric restrictive procedure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2013to Apr 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has met diabetic lab testing and all pre-procedural qualifications
- Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
- Subject has a BMI of > 30 and < 35
- Subject has history of obesity for > 2 yrs
- Subject has had no significant weight change (<5% of total body weight)in last 6 months
- Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline
Show all 10Show fewer
- Subject is a reasonable candidate for general anesthesia
- Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial
- Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
- Subject must be able to fully understand and be willing to sign the informed consent
Who cannot join
- Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure
- Mallampati (intubation) score greater than 3
- Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed
- Subject has history or present use of insulin or insulin derivatives for treatment of diabetes
- Subject has diabetes secondary to a specific disease
- Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years
Show all 31Show fewer
- Subject has history of inflammatory disease of GI tract
- Subject has a history of intestinal strictures or adhesions
- Subject has renal and/or hepatic insufficiency
- Subject has chronic pancreatic disease
- Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer
- Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility
- Subject has a history of any significant abdominal surgery
- Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis
- Subject has a hiatal hernia > 2cm
- Subject has chronic/acute upper GI bleeding conditions
- Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation
- Female subject is of childbearing age and not practicing effective birth control, is pregnant or is lactating
- Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Subject has cancer or life expectancy of < 2 yrs
- Subject has systemic infection in the body at the time of the plication procedure.
- Subject currently uses or has used over the counter or prescription weight loss medications in last 30 days or intends to use during follow-up Study period.
- Subjects who have started medications within the last 3 months that are known to cause weight gain
- Subjects undergoing chronic steroid therapy
- Subjects undergoing immunosuppressive therapy
- Subject has a history of drug or alcohol abuse
- Subject has a history of uncontrolled or poorly controlled psychiatric disease or suspected eating disorders
- Subject is non-ambulatory or has significant impairment of mobility
- Subject has known hormonal or genetic cause for obesity
- Subject is not in sufficient and stable medical health, as determined and evaluated by the Principal Investigator.
- Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas at Houston
Bellaire, Texas, 77401
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jackson Health System
Miami, Florida, 33176
St. Joseph's Regional Medical Center at New Jersey
Paterson, New Jersey, 07503
About this study
Official title: Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial
Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.
Read the detailed description
The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.
The primary endpoint of this study is evaluation of safety and feasibility of the procedure. All subjects for whom the plication procedure is initiated (defined as placement of the overtube) will be included in the safety analysis. The primary safety analysis will assess the occurrence of adverse events through 12 months after the plication procedure.
Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic intervention. Safety will be determined as no adverse events directly related to the procedure at 12 months.
Secondary Endpoints:
- Efficacy: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline:
- Percent excess weight loss (%EWL)
- Total weight lost (kg) and percent weight lost
- Change in (BMI) and percent change in BMI
- Change in waist circumference
- Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values
- Changes in quality of life measures as reported on Quality of Life questionnaire(s) (evaluated relative to baseline)
- Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to baseline)
- Durability: Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.
- Conditions
- Obesity, Body Weight, Overweight
- Being tested
- Endoscopic gastric restrictive procedure
- Keywords
- Obesity, BMI, Weight loss, Gastric restriction, Bariatrics
- Medical subject headings
- Obesity, Body Weight, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic gastric restrictive procedureDevice
Also called Apollo Overstitch Endoscopic Suturing System
Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic gastric restrictive procedure | Experimental | Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Receives: Device: Endoscopic gastric restrictive procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.
Measured: 12 months
Evaluation of Technical Feasibility of the Procedure
Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.
Measured: Day 0 - Procedure Day
Secondary outcomes (5)
Percent Excess Weight Loss
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss
Measured: 12 Months
Durability
Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.
Measured: 12 months
Percentage of Total Body Weight Loss
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss
Measured: 12 Months
BMI Loss (kg/m^2)
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)
Measured: 12 Months
Waist Circumference Loss (cm)
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionApr 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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Endosurgery, Inc.
- Responsible party
- Principal investigator, Christopher Thompson, Brigham and Women's Hospital
- Investigators
- Christopher C. Thompson, MD, MS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662024
- Sponsor's protocol ID
- 2012P-000799
- Acronym
- PROMISE
- Status last verified
- Feb 2017
- First submitted
- 15 Jun 2012
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data is available immediately. We will share the outcomes data if a request is made via email to the PI and the data transfer is completed between institutions. Identifying information will not be provided.
Publications
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.
PubMed 10432328Dindo D, Muller MK, Weber M, Clavien PA. Obesity in general elective surgery. Lancet. 2003 Jun 14;361(9374):2032-5. doi: 10.1016/S0140-6736(03)13640-9.
PubMed 12814714Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
PubMed 15616203Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based analysis. J Am Coll Surg. 2004 Oct;199(4):543-51. doi: 10.1016/j.jamcollsurg.2004.06.014.
PubMed 15454136Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc. 2002 Feb;16(2):230-3. doi: 10.1007/s004640080187. Epub 2001 Oct 5.
PubMed 11967669Jirapinyo P, Watson RR, Thompson CC. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc. 2012 Aug;76(2):435-9. doi: 10.1016/j.gie.2012.03.681. Epub 2012 May 31. No abstract available.
PubMed 22658388
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial
- ClinicalTrials.gov ID
- NCT01662024
- Acronym / sponsor ID
- PROMISE / 2012P-000799
- Conditions
- Obesity, Body Weight, Overweight
- Keywords
- Obesity, BMI, Weight loss, Gastric restriction, Bariatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Apollo Endosurgery, Inc.
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.
Detailed description
The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.
The primary endpoint of this study is evaluation of safety and feasibility of the procedure. All subjects for whom the plication procedure is initiated (defined as placement of the overtube) will be included in the safety analysis. The primary safety analysis will assess the occurrence of adverse events through 12 months after the plication procedure.
Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic intervention. Safety will be determined as no adverse events directly related to the procedure at 12 months.
Secondary Endpoints:
- Efficacy: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline:
- Percent excess weight loss (%EWL)
- Total weight lost (kg) and percent weight lost
- Change in (BMI) and percent change in BMI
- Change in waist circumference
- Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values
- Changes in quality of life measures as reported on Quality of Life questionnaire(s) (evaluated relative to baseline)
- Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to baseline)
- Durability: Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic gastric restrictive procedure | Experimental | Device: Endoscopic gastric restrictive procedureRestrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject has met diabetic lab testing and all pre-procedural qualifications
- Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
- Subject has a BMI of > 30 and < 35
- Subject has history of obesity for > 2 yrs
- Subject has had no significant weight change (<5% of total body weight)in last 6 months
Key exclusion criteria (31 listed)
- Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure
- Mallampati (intubation) score greater than 3
- Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed
- Subject has history or present use of insulin or insulin derivatives for treatment of diabetes
- Subject has diabetes secondary to a specific 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 |
|---|---|---|
| Endoscopic gastric restrictive procedureAlso: Apollo Overstitch Endoscopic Suturing SystemEndoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures | Device | Endoscopic gastric restrictive procedure |
Primary outcome
Number of Participants With Adverse Events
Time frame: 12 months
Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.
Evaluation of Technical Feasibility of the Procedure
Time frame: Day 0 - Procedure Day
Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.
5 secondary outcomes
Percent Excess Weight Loss
Time frame: 12 Months
Durability
Time frame: 12 months
Percentage of Total Body Weight Loss
Time frame: 12 Months
BMI Loss (kg/m^2)
Time frame: 12 Months
Waist Circumference Loss (cm)
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Background: PubMed 10432328Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.
- Background: PubMed 12814714Dindo D, Muller MK, Weber M, Clavien PA. Obesity in general elective surgery. Lancet. 2003 Jun 14;361(9374):2032-5. doi: 10.1016/S0140-6736(03)13640-9.
- Background: PubMed 15616203Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
- Background: PubMed 15454136Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based analysis. J Am Coll Surg. 2004 Oct;199(4):543-51. doi: 10.1016/j.jamcollsurg.2004.06.014.
- Background: PubMed 11967669Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc. 2002 Feb;16(2):230-3. doi: 10.1007/s004640080187. Epub 2001 Oct 5.
- Background: PubMed 22658388Jirapinyo P, Watson RR, Thompson CC. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc. 2012 Aug;76(2):435-9. doi: 10.1016/j.gie.2012.03.681. Epub 2012 May 31. No abstract available.
- Individual participant dataSharing planned: Yes. Data is available immediately. We will share the outcomes data if a request is made via email to the PI and the data transfer is completed between institutions. Identifying information will not be provided.
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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.
Christopher C. Thompson, MD, MS principal investigator
Brigham and Women's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic gastric restrictive procedure in people with Obesity and Body Weight, run by Brigham and Women's Hospital at 4 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 31 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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 30 Mar 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?
Number of Participants With Adverse Events (time frame: 12 months). The study lists 2 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 NCT01662024, which also lists 7 linked publications.
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 30 Mar 2017.