ObesityNCT00939055
StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
A study testing StomaphyX in people with Obesity, run by EndoGastric Solutions at 2 sites in United States.
Trial summary
The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is often associated with… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- StomaphyX
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Jun 2012
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At least 18 years of age and less than 65 years of age
- BMI of at least 35 and no more than 40
- At least 2 years post-RNYGB surgery
- Initially achieved at least 60% EBL and a BMI 35 or less
- Regained at least 20% of pre-RNYGB excess weight at screening
- Stable weight or continued failure to lose weight for at least 3 months
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- Enlarged gastric pouch (≥ 30 ml)
- Anatomy of upper GI judged suitable for revision using StomaphyX
- Completed successful nutritional screening
- Normal levels of vitamin D, iron/ferritin, calcium, and magnesium
- Absence of protein malnutrition confirmed by serum albumin > 3 g/dL
- Willing to cooperate with follow-up dietary recommendations and assessment tests
- Signed Informed Consent
Who cannot join
- Previous revisional bariatric surgery after RNYGB
- Esophageal stricture or any anatomic condition that precludes passage of the StomaphyX device to the gastric pouch
- Diabetes type I
- Causal factors for weight regain other than gastric pouch enlargement
- Serious complications experienced during and/or after RNYGB such as leaks, fistula, incisional hernia, ulcers, pulmonary embolism or deep venous thrombosis
- Pregnancy or plans of pregnancy in the next 12 months
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- Immunosuppression
- ASA > 3
- Life expectancy less than one year
- An eating disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Washington DC, American Psychiatric Association, 2000
- Active substance abuse
- Plans of smoking cessation in the next 12 months
- Treatment with weight-loss prescription drug therapy within three months preceding the screening
- Intention to use prescription drug therapy or the use of over-the-counter weight-loss preparations during the current study
- Current participant in another weight-loss study or other clinical trial
- Inflammatory bowel disease
- Presence of ulceration at the gastrojejunostomy anastomosis
- Portal hypertension
- Coagulation disorders or chronic use of anticoagulants
- Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Medical Center
Columbus, Ohio, 43210
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Randomized Controlled Trial of StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is often associated with distended gastric anatomy. Open and laparoscopic approaches for revision are associated with higher complication rates than de novo procedures. This study will evaluate the safety and effectiveness of a revisional incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss in post-RNYGB patients who have experienced weight regain.
Read the detailed description
The Roux-en-Y gastric bypass (RNYGB) is the most commonly performed bariatric procedure to treat morbid obesity 1. Numerous studies have documented the effectiveness of RNYGB in promoting excess weight loss (EWL) typically in the 65-80% range after 1.5 to 2 years 1. Despite the favorable short-term outcomes of this bariatric surgical procedure, approximately 10-40% of patients do not achieve successful long-term weight loss 2. The weight regain occurs typically within 2 to 7 years after RNYGB surgery and is associated primarily with dilation of the gastric pouch or stoma 3, 4. Several open and laparoscopic bariatric revision procedures have been used in an attempt to correct these dilations, but they all have been associated with serious complications such as perforations, obstruction, staple line disruption, blind loop syndrome, stoma ulcer, and incisional hernias 2, 5, 6. Because of this high rate of morbidity associated with revisional gastric bypass surgery, less invasive endoscopic procedures may become a preferred approach for weight regain after RNYGB 7, 8.
The StomaphyX delivery system with SerosaFuse fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device. The device uses vacuum to invaginate tissue through a port into a chamber and fasten it using the H shaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue. Durability of the SerosaFuse fasteners has been demonstrated during several clinical studies utilizing the EsophyX device 9-12.
Reason for Conducting the Present Study: The goal of this study was to investigate the safety and effectiveness of the StomaphyX device for revisional natural orifice surgery of the gastric pouch and gastrojejunostomy anastomosis (stoma) in RNYGB patients to reduce regained weight.
- Conditions
- Obesity
- Being tested
- StomaphyX, Sham procedure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StomaphyXDevice
Also called transoral incisionless fastening device
Transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
Sham procedureProcedure or surgery
Also called Placebo
False procedure
| Study group | Role | What they receive |
|---|---|---|
| StomaphyX | Experimental | Post-Roux-en-Y revisional surgery using the StomaphyX device. Receives: Device: StomaphyX |
| Sham Procedure | Sham comparator | No intervention Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.
Measured: 12 month
Secondary outcomes (1)
Assessment of Changes to Quality of Life (QOL) Using a Validated QOL Questionnaire
Quality of life as assessed by the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite); a ≥ 10 total score improvement from baseline (screening) will represent a clinically significant improvement.
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 posted14 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Based on futility analysis, study would not meet primary endpoint.
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 (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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoGastric Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anita P. Courcoulas, MD MPH FACS, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939055
- Sponsor's protocol ID
- D00764
- Status last verified
- Oct 2020
- First submitted
- 10 Jul 2009
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eid GM, McCloskey CA, Eagleton JK, Lee LB, Courcoulas AP. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients : a randomized clinical trial. JAMA Surg. 2014 Apr;149(4):372-9. doi: 10.1001/jamasurg.2013.4051.
PubMed 24554030
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
- ClinicalTrials.gov ID
- NCT00939055
- Acronym / sponsor ID
- D00764
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on futility analysis, study would not meet primary endpoint.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- EndoGastric SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Posted 5 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is often associated with distended gastric anatomy. Open and laparoscopic approaches for revision are associated with higher complication rates than de novo procedures. This study will evaluate the safety and effectiveness of a revisional incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss in post-RNYGB patients who have experienced weight regain.
Detailed description
The Roux-en-Y gastric bypass (RNYGB) is the most commonly performed bariatric procedure to treat morbid obesity 1. Numerous studies have documented the effectiveness of RNYGB in promoting excess weight loss (EWL) typically in the 65-80% range after 1.5 to 2 years 1. Despite the favorable short-term outcomes of this bariatric surgical procedure, approximately 10-40% of patients do not achieve successful long-term weight loss 2. The weight regain occurs typically within 2 to 7 years after RNYGB surgery and is associated primarily with dilation of the gastric pouch or stoma 3, 4. Several open and laparoscopic bariatric revision procedures have been used in an attempt to correct these dilations, but they all have been associated with serious complications such as perforations, obstruction, staple line disruption, blind loop syndrome, stoma ulcer, and incisional hernias 2, 5, 6. Because of this high rate of morbidity associated with revisional gastric bypass surgery, less invasive endoscopic procedures may become a preferred approach for weight regain after RNYGB 7, 8.
The StomaphyX delivery system with SerosaFuse fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device. The device uses vacuum to invaginate tissue through a port into a chamber and fasten it using the H shaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue. Durability of the SerosaFuse fasteners has been demonstrated during several clinical studies utilizing the EsophyX device 9-12.
Reason for Conducting the Present Study: The goal of this study was to investigate the safety and effectiveness of the StomaphyX device for revisional natural orifice surgery of the gastric pouch and gastrojejunostomy anastomosis (stoma) in RNYGB patients to reduce regained weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StomaphyX | Experimental | Device: StomaphyXPost-Roux-en-Y revisional surgery using the StomaphyX device. |
| Sham Procedure | Sham comparator | Procedure: Sham procedureNo intervention |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- At least 18 years of age and less than 65 years of age
- BMI of at least 35 and no more than 40
- At least 2 years post-RNYGB surgery
- Initially achieved at least 60% EBL and a BMI 35 or less
- Regained at least 20% of pre-RNYGB excess weight at screening
Key exclusion criteria (20 listed)
- Previous revisional bariatric surgery after RNYGB
- Esophageal stricture or any anatomic condition that precludes passage of the StomaphyX device to the gastric pouch
- Diabetes type I
- Causal factors for weight regain other than gastric pouch enlargement
- Serious complications experienced during and/or after RNYGB such as leaks, fistula, incisional hernia, ulcers, pulmonary embolism or deep venous thrombosis
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 |
|---|---|---|
| StomaphyXAlso: transoral incisionless fastening deviceTransoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications. | Device | StomaphyX |
| Sham procedureAlso: PlaceboFalse procedure | Procedure or surgery | Sham Procedure |
Primary outcome
Weight Loss
Time frame: 12 month
A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.
1 secondary outcome
Assessment of Changes to Quality of Life (QOL) Using a Validated QOL Questionnaire
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 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24554030Eid GM, McCloskey CA, Eagleton JK, Lee LB, Courcoulas AP. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients : a randomized clinical trial. JAMA Surg. 2014 Apr;149(4):372-9. doi: 10.1001/jamasurg.2013.4051.
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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.
Anita P. Courcoulas, MD MPH FACS principal investigator
University of Pittsburgh Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StomaphyX in people with Obesity, run by EndoGastric Solutions at 2 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 13 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 5 Jun 2014). 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?
Weight Loss (time frame: 12 month). 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 NCT00939055, 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 23 Nov 2020.