Objectives: The purpose of this study is to establish the safety of the product.This study is designed to evaluate the safety of the device in protecting the anastomotic junction created during a stoma reversal procedure. The objectives of this…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoints
Safety data will be gathered with respect to the number, timing, severity,
duration and resolution of device related adverse events occurring among study
subjects.
Secondary outcome
Secondary Endpoints
* Length of hospital stay
* Reoperation rate
* Readmission rate
* Number/type of additional procedures due to complications
* Evaluation of the delivery method of the sealant
Number of adverse events associated with known complications of ileostomy
reversal.
Known complications of ileostomy closure include:
* Anastomotic leak
* Wound infection
* Intra-abdominal abscess/sepsis
* Small bowel obstruction
* Incisional hernia
* Prolonged post-operative ileus
* Post-operative enterocutaneous fistula
Background summary
Protocol Title: Clinical Evaluation of the Cohera Sylys* Surgical Sealant as an
adjunct to standard bowel anastomosis closure
Protocol Number: PRO-106-0028
Sponsor: Cohera Medical, Inc.
209 Sandusky St.
Pittsburgh, PA 15212
412-231-1500
Principal coordinating investigator: Prof. Dr. Bemelman
Location: 2 sites in The Netherlands
Device name: Sylys*
Additional background information is given in chapter 2 of the protocol.
Study objective
Objectives:
The purpose of this study is to establish the safety of the product.
This study is designed to evaluate the safety of the device in protecting the
anastomotic junction created during a stoma reversal procedure.
The objectives of this clinical evaluation are:
* To determine the safety of the Sylys* device used during open ileostomy
reversal procedures.
* Examine the performance of the delivery method.
The primary hypothesis for this study is that Sylys* Surgical Sealant is a safe
adjunct to standard closure techniques during a stoma reversal procedure.
No claims regarding efficacy will be verified during this clinical
investigation.
The study is a prospective, non-randomized, one treatment group, un-blinded
study conducted on stoma reversal patients at 2 study centers. Subjects are
enrolled in the trial for a period of 90 days.
Study design
Prospective Design
This clinical investigation is an open-label, prospective, unblinded
multicenter study. The Patient Population to be studied will consist of a total
of 15 test subjects. The data will be collected at 2 sites.
Intervention
Follow up:
Clinical assessments will be performed pre-operatively, intra-operatively,
during hospital stay, at discharge from hospital, at 7 days (± 1 days), 30 days
(± 3 days) and 90 days (± 3 days) post operatively.
The number of subjects required for this clinical investigation is fifteen.
The estimated time needed to enroll this number is 60 days. The expected
duration of the clinical investigation is 5 months including 60 day enrollment
and the 90 day follow up periods.
Study burden and risks
Risks to patients in this study include all those risks currently associated
with ileostomy reversal procedures. These risks include, but are not limited
to, the following; nausea, headache, back pain, surgical site infection and
constipation.
If used as indicated, there are no known risks associated with the use of
Sylys* as a surgical sealant. There may be potential risks of device failure if
Sylys* is:
* Used in conjunction with other surgical adhesives or sealants, or other fluid
preparations.
* Used in patients with known or suspected allergies to urethane-based or
siloxane-based products.
It is possible that unanticipated risks may occur.
Sandusky St. 209
Pittsburgh PA 15212
US
Sandusky St. 209
Pittsburgh PA 15212
US
Listed location countries
Age
Inclusion criteria
* Be at least 18 years of age;
* Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
* Be scheduled for an ileostomy reversal procedure;
* Be willing to follow instructions for incision care;
* Agree to return for all follow-up evaluations specified in this protocol;
* Sign the informed consent.
Exclusion criteria
* Anesthesia Risk judged to be higher than ASA2
* Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
* Any condition involving compromised immune system
* Any condition known to effect wound healing, such as collagen vascular disease
* Known blood clotting disorder
* Be receiving antibiotic therapy for pre-existing condition or infection
* Concurrent use of fibrin sealants or other anastomosis care devices
* Be currently taking systemic steroids or immunosuppressive agents
* Have known or suspected allergy or sensitivity to any test materials or reagents
* Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43207.018.13 |