The primary objective is to evaluate the EndoRotor®*s ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the freedom from major complications. The
safety endpoint will include an assessment of the safety of the EndoRotor when
performing endoscopic necrosectomy. For the purpose of this study, the safety
evaluation shall include complications associated with endoscopic necrosectomy
through the 21 (+/-7) day follow-up period. Potential endoscopic
complications include perforation and bleeding.
Secondary outcome
* Successful clearance of necrosis in the collection treated during direct
endoscopic necrosectomy where success is defined as at least 70% of the
necrotic debris in the WOPN cavity is removed based on CT evaluation of
the cavity at the 21 (+/-7) day follow up visit.
* Assessment of total procedure time to achieve clearance of necrosis for all
procedures
* Assessment of adequacy of debridement
* Assessment of total number of procedures to achieve clearance of necrosis
* Assessment of length of hospital stay and utilization
* SF-36 Questionnaire
Background summary
Infected walled of pancreatic necrosis (WOPN) is a complication of acute
pancreatitis. Direct endoscopic intervention is a means to remove the necrosis
and improve patient recovery. Interscope completed direct endoscopic
necrosectomy procedures in the European Union and believes that use of the
EndoRotor will allow for a safe and effective direct endoscopic necrosectomy of
WOPN. Current techniques employ the use of instruments not designed for the
procedure such as endoscopic snares/jumbo forceps to blindly break up necrosis
followed by endoscopic retrieval baskets to blindly grasp necrotic debris. In
Europe, where the EndoRotor® has been used in human cases, it performed well in
direct endoscopic necrosectomy. The EndoRotor*s ability to resect tissue may
provide faster rates of removal and less endoscopic procedures in this patient
population.
In this study, Interscope will evaluate the EndoRotor*s ability to remove
walled off necrosis through direct endoscopic necrosectomy in patients
requiring endoscopic necrosectomy. The study will be conducted at primary
referral centers for this patient population.
Study objective
The primary objective is to evaluate the EndoRotor®*s ability to safely remove
non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with
walled off pancreatic necrosis
Study design
A prospective, single arm, open label, multi-center, trial to evaluate the
safety and effectiveness of the Interscope EndoRotor® Resection System in
subjects requiring direct endoscopic necrosectomy with walled off pancreatic
necrosis (WOPN). Total enrollment of 30 subjects with at least 15 enrolled in
the US.
Subjects will be debrided with the EndoRotor at least 2 days following initial
stent placement with a maximum of 4 EndoRotor procedures. A minimum of 2 days
is required between each EndoRotor procedure and all procedures need to be
completed within a 14 (+7/-0) day period. Follow up is completed to 21 (+/-7)
days after first EndoRotor debridement procedure.
Intervention
Following placement of EUS guided drainage and determination of the subjects
meeting I/E criteria a direct endoscopic necrosectomy procedure can be
performed at least 2 days following the EUS guided drainage. During the index
procedure the EndoRotor® will be set-up and used to resect all visible and
accessible necrotic debris. No resection is performed on the pancreatic wall
during this procedure. Multiple procedures can be performed to remove necrotic
tissue as required.
Study burden and risks
The EndoRotor procedure poses no new risks to the patient than the commonly
used mucosal resection techniques. As with all endoscopic resection and
ablation devices, the most common risks are perforation and bleeding requiring
intervention. Other commonly known risks to direct endoscopic necrosectomy
removal include the following:
* Stent dislodgment
* Delayed bleeding occurring after the patient has been discharged requiring
hospitalization and intervention
* Undiagnosed perforation resulting in free air in the peritoneum post-procedure
Risks related to endoscopy include:
* Bleeding
* Infection
* Damage to GI tract and surrounding tissue
Risks related to anesthesia include:
* Post operative confusion
* Heart attack
* Pneumonia
* Stroke
These are all common to established mucosal resection / ablation techniques and
endoscopists are well practiced in handling these events. There are no
additional risks that are particular to the EndoRotor® mechanical resection
device.
The potential benefits of the EndoRotor® device are as follows:
* May result in less time to resolution of WOPN
* Complete removal of necrotic debris requiring less treatments
100 Main St. Suite 100 Main St. Suite 108
Whitinsville, MA 01588
US
100 Main St. Suite 100 Main St. Suite 108
Whitinsville, MA 01588
US
Listed location countries
Age
Inclusion criteria
1. Subjects who are >22; inclusive of males and females.
2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication
to undergo endoscopic necrosectomy after having undergone EUS-guided drainage
3. Imaging suggestive of greater than or equal to 30% necrotic material
4. Walled off pancreatic necrosis size *6 cm and *22cm
5. Subject can tolerate repeated endoscopic procedures
6. Subject capable of giving informed consent.
7. Subjects with the ability to understand the requirements of the study, who have provided written informed
consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7)
days, as indicated.
Exclusion criteria
1. Subject unable to give informed consent.
2. Subject is unwilling to return for repeated endoscopies.
3. Documented Pseudoaneurysm > 1cm within the WOPN
4. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using
endoscopy or endoscopic ultrasound).
5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
6. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not
allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
7. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of
contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the
duration of study participation.
8. Patient is known to be currently enrolled in another investigational trial that could interfere with the
endpoint analyses of this trial.
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 |
|---|---|
| ClinicalTrials.gov | NCT03694210 |
| CCMO | NL67603.078.18 |