NCT01124357

Brief Summary

STUDY HYPOTHESIS: Does outpatient NovaSureTM endometrial ablation alleviate excessive menstrual bleeding and improve life quality more effectively than outpatient ThermachoiceTM endometrial ablation?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
Last Updated

May 17, 2010

Status Verified

May 1, 2006

Enrollment Period

1.4 years

First QC Date

March 18, 2010

Last Update Submit

May 14, 2010

Conditions

Menorrhagia

Keywords

Heavy menstrual bleedingmenorrhagiaThermachoiceTMNovaSureTMEndometrail Ablation

Outcome Measures

Primary Outcomes (1)

  • Amenorrhoea

    The objective of any treatment for HMB is to substantially reduce the amount of menstrual blood loss.Amenorrhoea rates are often chosen as the primary outcome measure in clinical trial of the effectiveness of endometrial ablation in women with HMB.

    6 months after the intervention.

Secondary Outcomes (1)

  • Visual analogue scale for assessment of pain

    24 hours

Study Arms (2)

novasure

ACTIVE COMPARATOR

Bipolar radio-frequency energy ablation of the endometrium by thermal therapy under impedance control. The bipolar current generated by the device produces a tapered depth of ablation with shallower ablation in the cornual regions / lower uterine segment and a deeper ablation in the mid-body of the uterus..

Device: NovaSure

thermachoice

OTHER

ThermachoiceTM III thermal balloon ablation

Device: thermachoice

Interventions

NovaSureDEVICE

Bipolar radio-frequency energy ablation of the endometrium by thermal therapy under impedance control. The bipolar current generated by the device produces a tapered depth of ablation with shallower ablation in the cornual regions / lower uterine segment and a deeper ablation in the mid-body of the uterus..

Also known as: Bipolar radio-frequency energy ablation
novasure
thermachoiceDEVICE

ThermachoiceTM III thermal balloon ablation

Also known as: Thermal balloon ablation
thermachoice

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
  • Premenopausal follicular follicle stimulating hormone (FSH) level of less than 40 IU/L.
  • Associated functional disability (negative impact on life quality).
  • Lack of response to medical treatment.
  • Prepared to undergo surgical treatment without general anaesthesia

You may not qualify if:

  • Women under 25 years
  • Suspected genital tract infection
  • Uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids \> 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
  • Uterine cavity length \>11cm
  • Adnexal pathology
  • Previous open myomectomy or endometrial ablation / resection and classical caesarian section
  • patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Smith PP, Malick S, Clark TJ. Bipolar radiofrequency compared with thermal balloon ablation in the office: a randomized controlled trial. Obstet Gynecol. 2014 Aug;124(2 Pt 1):219-225. doi: 10.1097/AOG.0000000000000395.

    PMID: 25004347DERIVED

  • Clark TJ, Samuel N, Malick S, Middleton LJ, Daniels J, Gupta JK. Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial. Obstet Gynecol. 2011 Jan;117(1):109-118. doi: 10.1097/AOG.0b013e3182020401.

    PMID: 21173651DERIVED

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Justin Mr Clark, MD MRCOG

    Birmingham Women's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 18, 2010

First Posted

May 17, 2010

Study Start

May 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2008

Last Updated

May 17, 2010

Record last verified: 2006-05