Dilated Gastric TissueNCT01003743
Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction
A study testing endolumenal tissue approximation in people with Dilated Gastric Tissue, run by USGI Medical at 1 site in United States.
Trial summary
Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also assess tissue anchor durability. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Dilated Gastric Tissue
- What is being tested?
- endolumenal tissue approximation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 19 to 64 years
- All sexes
- Adult
Who may be able to join
- Patient is > 18 years of age and < 65 years of age
- Patient is > 2 yrs post-Roux-en-Y bypass surgery
- Patient initially achieved > 50% EWL after Roux-en-Y bypass surgery
- Patient is a reasonable risk to undergo general anesthesia
- Patient is able to provide written informed consent
Who cannot join
- Patient has an esophageal stricture or other anatomy/condition that would preclude the use and passage of the endolumenal instruments
- Physician determines another causal factor for weight regain other than stoma or pouch dilation
- Patient is non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also assess tissue anchor durability.
- Conditions
- Dilated Gastric Tissue
- Being tested
- endolumenal tissue approximation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endolumenal tissue approximationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated Gastric TissueStudies 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
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003743
- Sponsor's protocol ID
- TP165
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction
- ClinicalTrials.gov ID
- NCT01003743
- Acronym / sponsor ID
- TP165
- Conditions
- Dilated Gastric Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- First posted
- 29 Oct 2009 (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.
Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also assess tissue anchor durability.
Study design
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient is > 18 years of age and < 65 years of age
- Patient is > 2 yrs post-Roux-en-Y bypass surgery
- Patient initially achieved > 50% EWL after Roux-en-Y bypass surgery
- Patient is a reasonable risk to undergo general anesthesia
- Patient is able to provide written informed consent
Key exclusion criteria (3 listed)
- Patient has an esophageal stricture or other anatomy/condition that would preclude the use and passage of the endolumenal instruments
- Physician determines another causal factor for weight regain other than stoma or pouch dilation
- Patient is non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise
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 |
|---|---|---|
| endolumenal tissue approximation | Device | – |
Primary outcome
Not reported in the source record.
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 29 Oct 2009.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endolumenal tissue approximation in people with Dilated Gastric Tissue, run by USGI Medical 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 3 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 29 Oct 2009. 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.
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.
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 29 Oct 2009.