Eligibility |
Pre-Application Inclusion criteria
- Understand and be able to follow the requirements of the protocol including signing
and dating an REB approved Informed Consent Form prior to undergoing any protocol
related procedures
- Adult healthy volunteers = 18 to = 60 years of age, male or female
- Female participants must fulfil one (1) of the following criteria:
i) Post-menopausal; defined as either amenorrhea = 12 months and confirmed with
follicle stimulating hormone test ii) Females of childbearing potential
participating in heterosexual sexual relations must be willing to use adequate
contraception from at least 30 days before the study and for the duration of the
study until 45 days post-intraperitoneal treatment. Adequate contraception
includes:
1. hormonal implant combined with a barrier method (male or female condom
diaphragm with spermicidal foam/gel/film/cream/suppository or cervical cap
with spermicide).
2. intrauterine system (IUS) combined with a barrier method (male or female
condom diaphragm with spermicidal foam/gel/film/cream/ suppository or
cervical cap with spermicide).
3. intrauterine device (IUD) combined with a barrier method (male or female
condom diaphragm with spermicidal foam/gel/film/cream/ suppository or
cervical cap with spermicide).
4. hormonal patch combined with a barrier method (male or female condom
diaphragm with spermicidal foam/gel/film/cream/ suppository or cervical cap
with spermicide).
5. hormonal contraceptive pills combined with a barrier method (male or female
condom diaphragm with spermicidal foam/gel/film/cream/ suppository or
cervical cap with spermicide).
6. double-barrier methods (e.g., male condom with diaphragm and spermicide,
male condom with cervical cap and spermicide).
7. complete abstinence as a method of contraception is acceptable if in line
with the subject's usual and preferred lifestyle.
- Male subjects who are non-vasectomized (or vasectomized less than six (6) months
prior device application) and have female partners of childbearing potential must
be willing to tell their female partner(s) that they are participating in a
research study, and use an effective birth control method when having
heterosexual intercourse, from treatment application until 45 days
post-intraperitoneal treatment. Effective methods of contraception for use by
males include:
i) using a condom with a female partner of child-bearing potential who is using
oral contraceptives, hormonal patch, implant or injection, intrauterine device,
or diaphragm with spermicidal foam/gel/film/ cream/suppository.
ii) complete abstinence as a method of contraception is acceptable if in line with the
subject's usual and preferred lifestyle.
- In good general health as evaluated by the Principal Investigator
- Has undergone a satisfactory physical and medical assessment with no clinically
significant and relevant abnormalities, comorbidities, chronic or acute infections
- No history of previous abdominopelvic surgery including laparoscopy, laparotomy,
caesarean section, or other access that could have resulted in development of
adhesions
- No symptoms, history, treatment or prior diagnosis of endometriosis, pelvic
inflammatory disease, chlamydia, polycystic ovaries, inflammatory bowel disease,
diverticulitis, irritable bowel syndrome or other condition likely to result in
abdominopelvic inflammation or sensitivity, or development of adhesions
- Have a negative pregnancy test within 1 day (24 hours) of device or control
application (female participants only)
- Is willing, able and likely to fully comply with clinical trial procedures and
restrictions including follow-ups
Pre-Application Exclusion Criteria
- Are unable to give their own written informed consent
- Current pregnancy including ectopic pregnancy within last 6 months (including any
previous ectopic pregnancy treated surgically) (female participants only)
- Positive pregnancy test (female participants only)
- Are breastfeeding (female participants only)
- Are within 3 months post-partum (female participants only)
- Are anticipated to attempt pregnancy within 45 days after intraperitoneal application
- Participant has donated blood in the following volumes:
i) Between 50 mL and 499 mL within 30 days prior to the screening visit ii) 500 mL or
more within 60 days prior to the screening visit
- Participant has a BMI of = 18.5 or = 30, and in the opinion of the Investigator does
not have - Has undergone previous abdominopelvic surgery including laparoscopy,
laparotomy, caesarean section, or other access that could have resulted in development
of adhesions
- Has had symptoms, history, treatment or prior diagnosis of any inflammatory condition
affecting the abdominopelvic cavity, including; endometriosis, pelvic inflammatory
disease, chlamydia, polycystic ovaries, inflammatory bowel disease (including Crohn's
disease, Ulcerative Colitis and Microscopic colitis), diverticulitis, irritable bowel
syndrome, intestinal obstructive disease or other condition likely to result in
abdominopelvic inflammation or sensitivity, or development of adhesions
- Have diabetes
- Have clinically significant abnormal blood results as reviewed by Principal
Investigator
- Have creatinine clearance <30 mL/min as per Cockcroft-Gault equation
- Concurrent use or anticipated use of systemic corticosteroids, antineoplastic agents
within 2 months of intraperitoneal application
- Participant has received immunosuppressant therapy within last 30 days
- Have had previous radiation therapy in thoracic or abdominopelvic cavity
- History of malignancy (excluding basal cell carcinoma)
- History of heparin-induced thrombocytopenia (HIT) or known sensitivity to heparin-like
products (including enoxaparin sodium)
- Have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic, -
Family history of blood or coagulation disorders
- Have any concomitant medical treatment including anticoagulant therapy,
over-the-counter medications and/or herbal supplements or teas within preceding 14
days of clinical trial unit - Active pelvic or abdominal infection or other active
infection with fever greater than 37.6°C
- Known or suspected allergy to brown seaweed, food allergies and/or presence of any
dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant"
- Any other severe allergic conditions (e.g., anaphylactic reactions, angioedema)
- Currently enrolled in another clinical study/trial or has been in another study within
the last 30 days
- Have received or is expected to receive any investigational product or investigational
technique within 30 days prior to or during enrolment
- Participants who are, in the opinion of the Investigator, unable to comply with the
clinical trial schedule and protocol evaluations
- Participants who, in the opinion of the Investigator, would not be suitable for
clinical trial participation
- Participants with clinically significant ECG or other screening visit abnormality
that, in the opinion of the Investigator, would not be suitable for clinical trial
participation
- Participant has current or any history of prior bladder or urinary injury; or history
of recurrent bladder or urinary problems, including recurrent urinary tract infections
in last 12 months; or a single occasion bladder or urinary problem, including cystitis
or proven urinary tract infection within the last 3 months
- Participant has suspected abdominal abscess
- Have a positive methicillin-resistant Staphylococcus aureus (MRSA) test at screening
only
- A known history or positive test result for human immunodeficiency virus (HIV),
chronic Hepatitis B surface antigen, or Hepatitis C antibody at screening only.
- Evidence of alcohol or substance abuse, or previous alcohol or substance abuse
- Participant not willing to refrain from use of alcohol throughout clincial trial unit
admission and for 48 hours prior to any clinic visit.
- A positive urine drug screen (Marijuana, Amphetamines, Phencyclidine, Barbiturates,
Cocaine, Opiates, Benzodiazepines).
- Participant not willing to refrain from egg donation from time of consent to 45 days
after
- Participant not willing to refrain from sperm donation from time of consent to 45 days
after intraperitoneal application (male participants only)
- Participant not willing to refrain from smoking or using any
tobacco/nicotine-containing products from at least 6 months prior to study device
application and for the entire duration of the study.
- Participant not willing to refrain from strenuous exercise/activity (for example heavy
lifting, weight training, intense aerobics classes etc.) for at least 72 hours prior
to admission to the
- Participant has a history of or has a current hernia.
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