Endoscopic Suturing (ES) Registry

Age Range:18 - Any
Start Date:October 29, 2018
End Date:December 2021
Contact:Sonya M Serra, MSc

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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.

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

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.

Inclusion Criteria:

1. Selected to undergo trans-orifice suturing prior to study enrollment

2. Age 18+ years

3. Patient ASA classification I, II, III, including emergency cases

4. Patient willing to provide informed consent, cooperate with post-operative
recommendations and follow-up assessment

Exclusion Criteria:

1. Patients who do not meet the clinical criteria for trans-orifice suturing

2. Under age 18 years

3. ASA classification IV

4. Unable to provide informed consent

5. Unable to participate in follow-up assessments

6. Uncorrectable coagulopathy at the time of endoscopic suturing

7. Any terminal disease that limits patient's survival to less than one year
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