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Interlace Medical Comparative Sedation Study

18 Years
65 Years
Not Enrolling
Uterine Fibroids, Polyps

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Trial Information

Interlace Medical Comparative Sedation Study

Forty subjects will be enrolled in a randomized, controlled study conducted at four
physician offices or day surgery settings. Subjects will be randomized 1:1 to a local
anesthetic group (Group #1 or Group #2). Subjects will undergo a hysteroscopic tissue
removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids.
Subsequent to the procedure, subjects will be randomized 1:1 within the local anesthetic
group to a post procedure pain management group (Group A or Group B). Subject self-reported
pain scores (as rated on an 11 point scale)will be compared at three time points:
Immediately post procedure, prior to discharge from the treatment facility, and at 48 hours
post procedure.

Inclusion Criteria:

- Healthy female between the ages of 18 and 65

- Subject must be able to understand, read and sign the study specific informed consent
forms after the nature of the study has been fully explained to her

- Subject is a pre-menopausal or peri-menopausal female, either nulliparous or parous

- Subject is indicated for myomectomy or polypectomy for benign pathology, based on
hysteroscopic, ultrasound, or saline infused sonogram assessment within 60 days

- Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the
following criteria. In cases of subjects with multiple intrauterine pathology,
classification is based as follows:

- All polyps

- A single Type 0 or Type 1 myoma ≤ 3 cm

- Polyps plus a single Type 0 or Type 1 myoma ≤ 3 cm

- Negative pregnancy test within 48 hours prior to planned index procedure and willing
to use reliable birth control for the next 30 days. Reliable birth control is defined
as a chemical or barrier method, including an oral contraceptive, injectable
contraceptive, or the combination of a spermicide and condoms

Exclusion Criteria:

- Known or suspected cancer, including breast, endometrial, and ovarian

- Subject has Type 2 myoma

- Contraindication and/or allergy to local anesthetic, or oral medications specified in
the treatment protocol

- Subject has a history of chronic narcotic use

- Previous uterine artery embolization or other uterine artery occlusion procedure
(Doppler or laparoscopic)

- Subject with blood borne pathogens-HIV, hepatitis B, CJD, etc.

- Subject plans to become pregnant within the study period

- Subject has an IUD at the time of the procedure. A subject may be enrolled in the
study if the IUD is removed prior to the treatment procedure

- Subject is taking an anticoagulant or antiplatelet medication other than low dose

- Active pelvic inflammatory disease or pelvic/vaginal infection

- Subject has a known or suspected coagulopathy or bleeding disorder

- Subject has a history of unmanaged endocrine disease

- Subject has current or past, acute or chronic psychiatric disorder which, in the
opinion of the Investigator, may preclude proper evaluation and follow-up

- Subject has history of auto-immune, inflammatory, or connective tissue disease

- Subject has a history of disease which increases the risk for fluid overload (i.e.
significant cardiac, hepatic, or renal dysfunction)

- Uncontrolled hypertension lasting two years or more

- Use of any experimental drug or device within 30 days prior to the screening visit

- The subject has a terminal illness that may prevent the completion of any follow-up

- Any employee or relative of an employee of the Sponsor company or any Investigator
site employee or relative of employees working on the study

- Subject has other co-morbid condition(s) that, in the opinion of the Investigator,
could limit the subject's ability to participate in the study or impact the
scientific integrity of the study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)

Outcome Time Frame:

Immediately post treatment

Safety Issue:


Principal Investigator

Andrea Lukes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Carolina Women's Research and Wellness Center


United States: Institutional Review Board

Study ID:

TMP 200902



Start Date:

November 2009

Completion Date:

July 2010

Related Keywords:

  • Uterine Fibroids
  • Polyps
  • morcellator
  • hysteroscope
  • myomectomy
  • polypectomy
  • uterine fibroids
  • uterine polyps
  • local anesthetic
  • cervical block
  • pain management
  • Leiomyoma
  • Myofibroma
  • Polyps



Wayne State UniversityDetroit, Michigan  48202
Minnesota Gynecology and SurgeryEdina, Minnesota  55435
Phoenix Gynecology ConsultantsPhoenix, Arizona  85013
Florida Woman CareBoca Raton, Florida  33431
Carolina Women's Research and Wellness CenterDurham, North Carolina  27713