SurgeryNCT03776188
Endoscopic Suturing (ES) Registry
An observational study of Surgery, run by American Gastroenterological Association at 11 sites in United States.
Trial summary
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- How many people
- 204 participants
- Where
- 11 sitesUnited States
- Study dates
- 29 Oct 2018to 30 Nov 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adults with a condition that can be treated with trans-orifice endoscopic surgery.
Who may be able to join
- Selected to undergo trans-orifice suturing prior to study enrollment
- Age 18+ years
- Patient ASA classification I, II, III, including emergency cases
- Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment
Who cannot join
- Patients who do not meet the clinical criteria for trans-orifice suturing
- Under age 18 years
- ASA classification IV
- Unable to provide informed consent
- Unable to participate in follow-up assessments
- Uncorrectable coagulopathy at the time of endoscopic suturing
- Any terminal disease that limits patient's survival to less than one year
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins Medical Institution
Baltimore, Maryland, 21224
Methodist Dallas Medical Center
Dallas, Texas, 75214
NorthShore University HealthSystem
Evanston, Illinois, 60201
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Borland Grover Clinic
Jacksonville, Florida, 32256
University of Arkansas
Little Rock, Arkansas, 72211
Northwell Health
Manhasset, New York, 11030
New York Presbyterian Hospital
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Washington University
St Louis, Missouri, 63110
About this study
Official title: Prospective Registry for Trans-Orifice Endoscopic Suturing Applications
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable.
To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.
Read the detailed description
To determine patient outcomes (survival, morbidity including hospitalization, additional re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing at predetermined intervals from the last endoscopic suturing procedure or at failure of the endoscopic suturing with conversion to another intervention such as surgery and compared to historical controls when applicable.
To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation of stents and bariatric revision.
To collect data on the common use endoscopic suturing therapy in other indications.
This prospective clinical study is a real-world registry and not a randomized controlled trial. Given the conditions commonly treated with endoscopic suturing and the potential lack of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all centers, randomization of participants is not possible nor ethical. In addition, there are clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or endoprosthetics may be appropriate and open and laparoscopic surgical approaches inappropriate from an ethical viewpoint. Given the multitude of currently available minimally invasive approaches to repair, it would be unethical to expose and randomize patients who are suitable for more minimally invasive approaches to a more invasive and inherently more morbid approach.
This outcomes study is external to the subject receiving the medical device treatment. Subjects will receive the medical device treatment regardless of study participation and the surgery is not part of this research. Subjects will be consented prior to their procedure, to obtain basic follow-up information. If the subject provides informed consent to participate in the registry, then site staff will follow the participant's clinical data for the period of the registry. Site staff may also contact the subject(s) during their standard clinic visit or via the telephone and obtain information on: overall health, specific events related to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.
The clinical data will be collected during usual procedure follow-ups. This will include recording patient demographics, medications, testing results, comorbidities, body mass index, and reason for clinical care visit. If during the follow-up period, the subject undergoes additional clinically indicated procedures or hospitalizations for procedure related indications then the site will submit this information to the registry.
All procedures and device use will be performed as clinically indicated and as directed by the treating physician. All information requested as part of this registry will be obtained from clinical data obtained as part of study.
- Conditions
- Surgery
- Keywords
- Endoscopic Suturing, Bariatric Revision, Stent Fixation, Bariatric Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no groups - observational study | no groups - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dislocation of Stent - distance
Change in the position measured using distance (centimeters).
Measured: Change at 2 weeks, 30 days, 3 months
Dislocation of Stent - location
Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter
Measured: Change at 2 weeks, 30 days, 3 months
Migration Rate of Stent - placement
Distal from placement over time (yes or no)
Measured: Change at 2 weeks, 30 days, 3 months
Migration Rate of Stent - replaced
Stent replaced or re-structured over time (yes or no)
Measured: Change at 2 weeks, 30 days, 3 months
Migration Rate of Stent - sutures
Number of intact Sutures
Measured: Change at 2 weeks, 30 days, 3 months
Migration Rate of Stent - removal
Days to removal and replacement
Measured: Change at 2 weeks, 30 days, 3 months
Excess Weight Loss
Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.
Measured: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
Total Weight Loss
Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.
Measured: Measured at 2 weeks, 30 days, 3 months, 6 months, 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 Dec 2018
- Study start29 Oct 2018
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- American Gastroenterological Association
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Endosurgery, Inc.
- Responsible party
- Sponsor
- Investigators
- Jennifer Maranki, MD, Principal investigator, Penn State Milton S. Hershey School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776188
- Sponsor's protocol ID
- ES Registry 2-682-101
- Status last verified
- Dec 2021
- First submitted
- 3 Nov 2018
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry for Trans-Orifice Endoscopic Suturing Applications
- ClinicalTrials.gov ID
- NCT03776188
- Acronym / sponsor ID
- ES Registry 2-682-101
- Conditions
- Surgery
- Keywords
- Endoscopic Suturing, Bariatric Revision, Stent Fixation, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- American Gastroenterological AssociationUniversity, hospital or other
- Collaborators
- Apollo Endosurgery, Inc.
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 Dec 2018 (actual)
- 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.
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable.
To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.
Detailed description
To determine patient outcomes (survival, morbidity including hospitalization, additional re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing at predetermined intervals from the last endoscopic suturing procedure or at failure of the endoscopic suturing with conversion to another intervention such as surgery and compared to historical controls when applicable.
To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation of stents and bariatric revision.
To collect data on the common use endoscopic suturing therapy in other indications.
This prospective clinical study is a real-world registry and not a randomized controlled trial. Given the conditions commonly treated with endoscopic suturing and the potential lack of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all centers, randomization of participants is not possible nor ethical. In addition, there are clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or endoprosthetics may be appropriate and open and laparoscopic surgical approaches inappropriate from an ethical viewpoint. Given the multitude of currently available minimally invasive approaches to repair, it would be unethical to expose and randomize patients who are suitable for more minimally invasive approaches to a more invasive and inherently more morbid approach.
This outcomes study is external to the subject receiving the medical device treatment. Subjects will receive the medical device treatment regardless of study participation and the surgery is not part of this research. Subjects will be consented prior to their procedure, to obtain basic follow-up information. If the subject provides informed consent to participate in the registry, then site staff will follow the participant's clinical data for the period of the registry. Site staff may also contact the subject(s) during their standard clinic visit or via the telephone and obtain information on: overall health, specific events related to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.
The clinical data will be collected during usual procedure follow-ups. This will include recording patient demographics, medications, testing results, comorbidities, body mass index, and reason for clinical care visit. If during the follow-up period, the subject undergoes additional clinically indicated procedures or hospitalizations for procedure related indications then the site will submit this information to the registry.
All procedures and device use will be performed as clinically indicated and as directed by the treating physician. All information requested as part of this registry will be obtained from clinical data obtained as part of study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no groups - observational study | – | –no groups - observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with a condition that can be treated with trans-orifice endoscopic surgery.
Key inclusion criteria (4 listed)
- Selected to undergo trans-orifice suturing prior to study enrollment
- Age 18+ years
- Patient ASA classification I, II, III, including emergency cases
- Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment
Key exclusion criteria (7 listed)
- Patients who do not meet the clinical criteria for trans-orifice suturing
- Under age 18 years
- ASA classification IV
- Unable to provide informed consent
- Unable to participate in follow-up assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dislocation of Stent - distance
Time frame: Change at 2 weeks, 30 days, 3 months
Change in the position measured using distance (centimeters).
Dislocation of Stent - location
Time frame: Change at 2 weeks, 30 days, 3 months
Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter
Migration Rate of Stent - placement
Time frame: Change at 2 weeks, 30 days, 3 months
Distal from placement over time (yes or no)
Migration Rate of Stent - replaced
Time frame: Change at 2 weeks, 30 days, 3 months
Stent replaced or re-structured over time (yes or no)
Migration Rate of Stent - sutures
Time frame: Change at 2 weeks, 30 days, 3 months
Number of intact Sutures
Migration Rate of Stent - removal
Time frame: Change at 2 weeks, 30 days, 3 months
Days to removal and replacement
Excess Weight Loss
Time frame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.
Total Weight Loss
Time frame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.
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 Dec 2021.
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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.
Jennifer Maranki, MD principal investigator
Penn State Milton S. Hershey School of Medicine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by American Gastroenterological Association at 11 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 4 inclusion and 7 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Dislocation of Stent - distance (time frame: Change at 2 weeks, 30 days, 3 months). The study lists 8 primary outcomes in all. 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 7 Dec 2021.