ObesityPhase 1NCT01682733
Endoscopic Gastric Reduction for Weight Management
A Phase 1 study testing Botulinum toxin and Overstitch Endoscopic Suturing System in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- Botulinum toxin and Overstitch Endoscopic Suturing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body Mass Index (BMI) between 30 and 40
- Age >18 and ≤50
- Stable weight for 3 months (within 5% of BMI)
- Normal basic labs (CBC, chemistry profile, creatinine)
- Negative pregnancy test for females >18 or ≤ 50
Who cannot join
- Diabetes
- Unstable coronary artery disease
- Heart failure
- Cardiac arrhythmia
- Cardiac valvular disease
- Obstructive of interstitial lung disease
Show all 15Show fewer
- Females of child-bearing age >18 or ≤ 50 who are pregnant or lactating
- Mallampati score of 4
- ASA 3 or above
- Previous gastric surgery
- Ulcer disease
- Gastroparesis,
- > 5 cm Hiatal hernia
- Congenital anomalies of the GI tract
- Currently on or prescribed a medication known to affect weight within 3 months of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study
The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.
- Conditions
- Obesity
- Being tested
- Botulinum toxin, Overstitch Endoscopic Suturing System
- Keywords
- Obesity, Weight loss, Gastric reduction (volume), BMI 30-40
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
Also called Botox
In this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty.
Overstitch Endoscopic Suturing SystemDevice
The gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin at injection site | Experimental | All subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected. Receives: Drug: Botulinum toxin; Device: Overstitch Endoscopic Suturing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Bariatric Quality of Life (BQL) Questionaire
Measured: baseline to 3 months
Secondary outcomes (1)
Change from baseline Three factor Eating Questionnaire (TFEQ-R21)
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
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.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barham K. Abu Dayyeh, M.D., Mayo Clinic
- Investigators
- Barham K AbuDayyeh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682733
- Sponsor's protocol ID
- 12-003195
- Status last verified
- Apr 2015
- First submitted
- 27 Aug 2012
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, Gostout CJ. Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals. Clin Gastroenterol Hepatol. 2017 Jan;15(1):37-43.e1. doi: 10.1016/j.cgh.2015.12.030. Epub 2015 Dec 31.
PubMed 26748219
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT01682733
- Acronym / sponsor ID
- 12-003195
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Gastric reduction (volume), BMI 30-40
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Sep 2012 (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 proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin at injection site | Experimental | Drug: Botulinum toxin, Device: Overstitch Endoscopic Suturing SystemAll subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) between 30 and 40
- Age >18 and ≤50
- Stable weight for 3 months (within 5% of BMI)
- Normal basic labs (CBC, chemistry profile, creatinine)
- Negative pregnancy test for females >18 or ≤ 50
Key exclusion criteria (15 listed)
- Diabetes
- Unstable coronary artery disease
- Heart failure
- Cardiac arrhythmia
- Cardiac valvular 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 |
|---|---|---|
| Botulinum toxinAlso: BotoxIn this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty. | Drug | Botulinum toxin at injection site |
| Overstitch Endoscopic Suturing SystemThe gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System. | Device | Botulinum toxin at injection site |
Primary outcome
Change from baseline Bariatric Quality of Life (BQL) Questionaire
Time frame: baseline to 3 months
1 secondary outcome
Change from baseline Three factor Eating Questionnaire (TFEQ-R21)
Time frame: baseline to 3 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 7 Apr 2015.
- Derived from this study: PubMed 26748219Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, Gostout CJ. Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals. Clin Gastroenterol Hepatol. 2017 Jan;15(1):37-43.e1. doi: 10.1016/j.cgh.2015.12.030. Epub 2015 Dec 31.
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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.
Barham K AbuDayyeh, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum toxin and Overstitch Endoscopic Suturing System in people with Obesity, run by Mayo Clinic at 1 site 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 5 inclusion and 15 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 7 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline Bariatric Quality of Life (BQL) Questionaire (time frame: baseline to 3 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 NCT01682733, 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 7 Apr 2015.