Gastrointestinal FistulaPhase 1NCT01303653
Endoscopic Treatment of Intestinal Fistulas and Perforations
A Phase 1 study testing endoscopic closure of gastrointestinal fistulas and perforations in people with Gastrointestinal Fistula and Gastrointestinal Perforation, run by The Oregon Clinic at 1 site in United States.
Trial summary
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastrointestinal Fistula, Gastrointestinal Perforation
- What is being tested?
- endoscopic closure of gastrointestinal fistulas and perforations
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastrointestinal fistula and perforation
- Ability to undergo general anesthesia
- Ability to give informed consent
Who cannot join
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Contraindicated for colonoscopy
- BMI ≥ 40
- Presence of esophageal stricture
- Altered gastric anatomy
- Intraabdominal abscess or severe inflammation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Good Samaritan Hospital, Legacy Health System
Portland, Oregon, 97210
Lee L Swanstrom, MD, 503-281-0561, lswanstrom@aol.com
Erwin Rieder, MD
About this study
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.
Read the detailed description
Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.
Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.
- Being tested
- endoscopic closure of gastrointestinal fistulas and perforations
- Keywords
- endoscopic tissue closure,, gastro-gastric fistulas,, gastrointestinal perforations
- Medical subject headings
- Digestive System Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic closure of gastrointestinal fistulas and perforationsProcedure or surgery
Also called Either the Tissue Apposition System (Ethicon Endosurgery), or the Overstitch (Apollo Endosurgery), will be used within this study for tissue closure
novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
elective endoscopy to evaluate tissue closure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal FistulaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Oregon Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303653
- Sponsor's protocol ID
- LEG 1280
- Status last verified
- Jul 2010
- First submitted
- 24 Feb 2011
- Last updated
- 28 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Intestinal Fistulas and Perforations
- ClinicalTrials.gov ID
- NCT01303653
- Acronym / sponsor ID
- LEG 1280
- Keywords
- endoscopic tissue closure,, gastro-gastric fistulas,, gastrointestinal perforations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Oregon ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (estimated)
- First posted
- 25 Feb 2011 (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.
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.
Detailed description
Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.
Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gastrointestinal fistula and perforation
- Ability to undergo general anesthesia
- Ability to give informed consent
Key exclusion criteria (6 listed)
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Contraindicated for colonoscopy
- BMI ≥ 40
- Presence of esophageal stricture
- Altered gastric anatomy
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 closure of gastrointestinal fistulas and perforationsAlso: Either the Tissue Apposition System (Ethicon Endosurgery), or the Overstitch (Apollo Endosurgery), will be used within this study for tissue closurenovel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations | Procedure or surgery | – |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 6 months
elective endoscopy to evaluate tissue closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2011.
Related trials for Gastrointestinal Fistula
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Active, not recruitingPhase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Anal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
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 endoscopic closure of gastrointestinal fistulas and perforations in people with Gastrointestinal Fistula and Gastrointestinal Perforation, run by The Oregon 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 3 inclusion and 6 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 28 Feb 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee L Swanstrom, MD (503 281 0561, lswanstrom@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as a measure of safety and tolerability (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 28 Feb 2011.